The US Food and Drug Administration (FDA) has issued draft guidance, CMC Postapproval Manufacturing Changes for Specified ...
The US Senate has voted to pass The FDA Reauthorization Act, which reauthorizes user fees for prescription drugs, generic ...
The US Senate voted to pass The FDA Reauthorization Act, which reauthorizes user fees for prescription drugs, generic ...
The US Food and Drug Administration (FDA) has released draft goals and procedures for a potential user fee program for nonprescription ...
The US Food and Drug Administration (FDA) has announced its intent to establish a pilot-project program under the Drug Supply ...
Following the passage in the US House of Representatives of a bill that would reauthorize user fees for prescription drugs, ...
The US Food and Drug Administration (FDA) Commissioner Scott Gottlieb highlighted the staffing priorities at the agency ...
The US Food and Drug Administration (FDA) has provided details of the implementation of the 21st Century Cures Act , which ...
The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) are stepping up ...
The US Food and Drug Administration (FDA) has issued draft guidance, Product Identifier Requirements Under the Drug Supply ...
The US Food and Drug Administration (FDA) has unveiled a strategic plan to eliminate the agency’s existing orphan designation ...
The European Federation of Pharmaceutical Industries and Associations (EFPIA), which represents the pharmaceutical industry ...
Among the decisions made at its most recent meeting held May 27 to June 1, 2017 in Montreal, Canada, the International Council ...
The US Food and Drug Administration (FDA) will hold a public meeting on July 18, 2017 to discuss ways to improve the generic-drug ...
The US Food and Drug Commissioner Scott Gottlieb issued a statement to further amplify on the agency's plan to address ...
The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the US Food and ...
In a landmark decision, the US Supreme Court ruled in favor of biosimilar developers regarding notification requirements ...
The US Senate Committee on Health, Education, Labor and Pensions (HELP) will hold a hearing next week, on Tuesday June 13, ...
In a vote of 54-0, the Energy and Commerce Committee of the US House of Representatives voted to advance the bill, The ...
The European Medicines Agency (EMA) and the European Commission have published guidance to help pharmaceutical companies ...
The new Commissioner of the US Food and Drug Administration (FDA), Dr. Scott Gottlieb, testified before the Subcommittee ...
President Donald Trump's FY 2018 budget proposal for the FDA, released this week, sets up a battle with Congress as the ...
Reflecting the changing nature of drug development to precision medicines, the US Food and Drug Administration (FDA) has ...
A report by the European Medicines Agency (EMA) shows that in 2016, European inspectors issued non-GMP compliance statements ...
Scott Gottlieb, MD, the new Commissioner of the US Food and Drug Administration (FDA), addressed his staff for the first ...
Tom Price, the US Secretary of Health and Human Services (HHS), advanced the Administration's budget blueprint in calling ...
For the first time in more than 20 years, Canada is proposing changes to its drug-pricing regulations, including a proposal ...
The US Senate has confirmed the nomination of Scott Gottlieb, MD, as the next Commissioner of the US Food and Drug Administration ...
The European Medicines Agency (EMA) has notified marketing authorization holders (MAHs) to prepare for drug authorization ...
At a recent meeting held between European Medicines Agency (EMA) officials and the heads of the National Competent Authorities ...
The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) released a new report on the trends from its inspection ...
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have released a report on the results ...
The Pharmaceutical Research and Manufacturers of America (PhRMA) provided comments to a recent report by the US Food and ...
Leaders of the US House of Representatives and Senate health committees have released a discussion draft of bipartisan legislation, ...
The European Parliament has passed a resolution in early April 2017 that outlines the provisions for the UK’s exit from ...
Industry stakeholders, including Pfizer and QuintilesIMS, have issued comments in response to the US Food and Drug Administrations ...
In a hearing of the US Senate Committee on Health, Education, Labor and Pensions held in early April 2017, representatives ...
Scott Gottlieb, MD, the nominee for US Food and Drug Administration (FDA) Commissioner, testified before Congress in a hearing ...
The US Food and Drug Administrations (FDA) Center for Drug Evaluation and Research (CDER) has outlined priority goals in ...
The US Food and Drug Administration and the European Commission (EC) have adopted an agreement whereby US and European Union ...
The Generic Pharmaceutical Association, a trade group representing generic pharmaceutical and biosimilar companies, has ...
The European Directorate for the Quality of Medicines and Healthcare (EDQM), the standards-setting organization for pharmacopeial ...
Prime Minister Theresa May in a speech this week provided a 12-point plan of broad objectives of the UK plans to exit the ...
The US Food and Drug Administration has issued draft guidance, Considerations in Demonstrating Interchangeability With ...
The US Food and Drug Administration (FDA) has issued final guidance, Clinical Pharmacology: Data to Support a Demonstration ...
The Center for Drug Evaluation and Research (CDER) in the US Food and Drug Administration (FDA) has announced the formation ...
The US Food and Drug Administration (FDA) and the Center for Drug Evaluation and Research and Small Business and Industry ...
The US Food and Drug Administration (FDA) and the generic drug manufacturing industry —including representatives of generic ...
The US Food and Drug Administration has issued draft guidance, Regulatory Classification of Pharmaceutical Co-Crystals, ...
The European Medicines Agency (EMA) has adopted a new chapter to its guidelines on good pharmacovigilance practices (EU-GVP), ...
The European Medicines Agency’s (EMA) Committee for Advanced Therapies (CAT) is organizing a workshop on November 15 and ...
The European Medicines Agency (EMA) has released n ew good manufacturing practice (GMP) guidance to ensure the integrity ...
The UK government announced that the Office for Life Sciences will continue to be a joint unit across the Department of ...
The European Medicines Agency (EMA) has announced some organizational adjustments and important strategic amendments of ...
The European Medicines Agency (EMA) has published a draft guideline to support and guide the use of innovative modelling ...
The US Food and Drug Administration (FDA)has approved safety labeling changes for a class of antibiotics, called fluoroquinolones, ...
The US Food and Drug Administration (FDA) has announced the rates for abbreviated new drug applications (ANDAs), prior approval ...
The European Medicines Agency (EMA), in cooperation with the European Commission and the member states of the European Union ...
The European Medicines Agency (EMA) has recommended suspending a number of nationally approved medicines for which bioequivalence ...
The European Medicines Agency (EMA) has assured that its procedures and work stream are not affected by the United Kingdom’s ...
The US Food and Drug Administration (FDA) has issued the Quality Metrics Technical Conformance Guide, a technical specification ...
Industry group representing innovator drug companies and generic drug companies have taken opposite positions regarding ...
The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have set up a new cluster on patient engagement. ...
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Veterinary Use (CVMP) has appointed Dr. David ...
President Barack Obama signed into law legislation that reformed the Toxic Control Substances Control Act (TSCA). TSCA, ...
The US Food and Drug Administration (FDA) has issued draft guidance, Quality Attribute Considerations for Chewable Tablets, ...
As of June 13, 2016, all periodic safety update reports (PSURs) for human medicines authorized in the European Union (EU) ...
The US Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, has taken ...
The US Food and Drug Administration (FDA) has re-iterated its position to include suffixes in its naming conventions for ...
The European Medicines Agency (EMA) has released the outcome of the assessment of the first batch of applications received ...
The European Medicines Agency (EMA) has published a report from a multi-stakeholder expert meeting held on May 27, 2016 ...
The European Medicines Agency (EMA) has published its 2015 annual report to highlight its key activities and goals. ...
The White House Office of Science and Technology Policy (OSTP), in collaboration with federal agencies and private-sector ...
To improve protection for workers from cancer-causing chemicals, the European Commission has proposed changes to the Carcinogens ...
In an article published in The New England Journal of Medicine , two representatives of the European Medicines Agency (EMA), ...
The US Food and Drug Administration (FDA) will hold a public meeting on June 10, 2016 in Silver Spring, Maryland, to ...
The US Food and Drug Administration has issued draft guideance, Chronic Hepatitis C Virus Infection: Developing Direct-Acting ...
The US Food and Drug Administration (FDA) has issued draft guidance, Special Protocol Assessment, to specify t the procedures ...
The US Food and Drug Administration (FDA) has issued draft guidance, Assay Development and Validation for Immunogenicity ...
The European Medicines Agency (EMA) has published new guidance on the use of patient-reported outcome (PRO) measures in ...
The US Food and Drug Administration (FDA) has issued draft guidance, Comparability Protocols for Human Drugs and Biologics: ...
The European Medicines Agency (EMA) and the European network for Health Technology Assessment (EUnetHTA) have published ...
A new industry body, the British Biosimilars Association (BBA), has been formally launched with the sole focus of increasing ...
The US Food and Drug Administration has issued draft guidance, Data Integrity and Compliance With CGMP, to clarify the ...
The US Food and Drug Administration has issued final guidance, Safety Considerations for Product Design to Minimize Medication ...
The European Medicines Agency (EMA) has published a preliminary version of its draft reflection paper that outlines a framework ...
The US Food and Drug Administration has issued draft guidance, Labeling for Biosimilar Products, to assist applicants ...
The US Food and Drug Administration (FDA) has issued final guidance, Contents of a Complete Submission for the Evaluation ...
The European Pharmacopoeia (Ph. Eur.) Commission elected Dr Tobias Gosdschan as its chair for a term from June 2016 to June ...
The European Pharmacopoeia (Ph. Eur.) Commission adopted a revision of its monograph for Water for Injections (0169). Up ...
The European Medicines Agency (EMA) has published a report on its pilot on parallel scientific advice with health-technology-assessment ...
In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the US Food ...
The US Food and Drug Administration (FDA) has issued a draft guidance intended to support industry in its development of ...
India's Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) have issued proposed ...
The Swiss Agency for Therapeutic Products (Swissmedic), the national drug regulatory agency for Switzerland, reports that ...
The European Medicines Agency (EMA) has launched its new PRIME (PRIority MEdicines) scheme to strengthen support to medicines ...
The European Medicines Agency (EMA) has published a revision of Module V of the good pharmacovigilance practices (GVP) ...
The US Food and Drug Administration (FDA) has issued final guidance, Completeness Assessments for Type II API DMFs Under ...
In response to concerns about substandard and counterfeit medicines and a growing demand for quality-assured medicines in ...
The MEDICRIME Convention, aninternational treaty against counterfeit medical products and similar crimes involving threats ...
The European Medicines Agency (EMA) and the European Commission (EC) have prepared an implementation plan for centrally ...
The European Medicines Agency (EMA) has established a task force of European experts with specialized knowledge in vaccines, ...
As part of the federal budget process, the US Food and Drug Administration is requesting a total budget of $5.1 billion ...
The European Medicines Agency (EMA) has released a revised guideline on medicines for the treatment of Alzheimer’s disease ...
The US Food and Drug Administration (FDA) published its guidance agenda for calendar year 2016 and identified the new and ...
The Biotechnology Industry Organization (BIO) has changed its name to the Biotechnology Innovation Organization (BIO). ...
The US Food and Drug Administration (FDA) has issued draft guidance, Advancement of Emerging Technology Applications to ...
The European Medicines Agency (EMA) Management Board and the Heads of Medicines Agencies (HMA) have adopted a common strategy ...
The Associated Chambers of Commerce & Industry of India (ASSOCHAM) and the research firm, RNCOS, have issued a report highlighting ...
The European Medicines Agency (EMA) Executive Director Guido Rasi outlined his vision for his five-year mandate at the helm ...
President Barack Obama has signed into law, the "Improving Regulatory Transparency for New Medical Therapies Act," which ...
The European Medicines Agency (EMA) has published a good practice guide on medication errors to improve the reporting, evaluation, ...
Professor Guido Rasi has taken office as executive director of the European Medicines Agency (EMA). Professor Rasi is ...
The European Medicines Agency (EMA) has released a draft scientific guideline that outlines how post-authorization efficacy ...
The European Medicines Verification Organization (EMVO) and the European Directorate for the Quality of Medicines & HealthCare ...
The NSF Health Sciences Certification, LLC (NSF), which provides testing, auditing, certification, and training for the ...
The International Council for Harmonization (ICH), formerly the International Conference on Harmonization, held the inaugural ...
The United States Pharmacopeial Convention (USP) has submitted its comments on the US Food and Drug Administration’s (FDA) ...
The US Food and Drug Administration (FDA) has issued revised draft guidance, Liposome Drug Products Chemistry, Manufacturing, ...
The European Medicines Agency (EMA) has launched a public consultation on the key principles of its new PRIME scheme. PRIME ...
The European Medicines Agency (EMA) has launched an initiative on patient registries aimed at making better use of existing ...
The Medicines and Healthcare products Regulatory Agency (MHRA), the UK's regulatory authority, has signed a memorandum of ...
The European Medicines Agency’s (EMA’s) management board has nominated Professor Guido Rasi as the executive director of ...
The European Medicines Agency (EMA) has released a draft guideline for public consultation on the use of pharmacokinetics ...
The European Medicines Agency’s (EMA) Management Board will meet on October 1, 2015 for an extraordinary session to nominate ...
President Barack Obama has announced his intent to nominate Dr. Rob Califf as the next Commissioner of the US Food and Drug ...
Stakeholders in the European healthcare and pharmaceutical industry have published the Riga Roadmap, an action plan to make ...
The US Food and Drug Administration (FDA) has issued final guidance, Q3D Elemental Impurities in line with the guideline ...
The US Food and Drug Administration (FDA) has issued draft guidance, Formal Dispute Resolution: Appeals Above the Division ...
The European Medicines Agency (EMA) is organizing a workshop on December 7, 2015 to discuss the approach that should be ...
The European Medicines Agency (EMA) began its full medical literature monitoring service on September 1, 2015. A total of ...
The US Food and Drug Administration (FDA) has issued draft guidance, Nonproprietary Naming of Biological Products; Draft ...
The European Medicines Agency has released an addendum to the International Conference on Harmonization of Technical Requirements ...
The European Commission (EC) has issued his draft regulations to detail the rules for the implementation of obligatory safety ...
The US Food and Drug Administration (FDA) has issued draft guidance, Botanical Drug Development, to describe the Center ...
The US Food and Drug Administration (FDA) has issued draft guidance, Rare Diseases:Common Issues in Drug Developmen t ...
The members of the GMP Committee of the International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) ...
The European Medicines Agency (EMA) Management Board has endorsed the European Union (EU) Telematics Strategy and Implementation ...
The US Food and Drug Administration (FDA) has issued draft guidance, Dissolution Testing and Specification Criteria for ...
The US Food and Drug Administration (FDA) has issued draft guidance, Request for Quality Metrics, to explain how the Center ...
The US Food and Drug Administration (FDA) has issued final guidance, Analytical Procedures and Methods Validation for Drugs ...
The European Medicines Agency (EMA) has revised its guidelines on the implementation of accelerated assessment and conditional ...
The European Medicines Agency (EMA) is launching a 12-month pilot to encourage companies to seek scientific advice for post-authorization ...
At its July 2015 meeting, the European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) voted to prolong ...
The European Medicines Agency (EMA) is launching a public register of parallel distribution notices to provide a more transparent ...
The European Medicines Agency (EMA) has released for consultation product-specific guidance on bioequivalence studies for ...
The International Conference on Harmonization (ICH) reports that its Addendum, "Assessment and Control of DNA Reactive (Mutagenic) ...
The US Food and Drug Administration (FDA) is amending its regulations to implement certain drug shortages provisions of ...
The European Medicines Agency (EMA) has published the outcome of a workshop that explored how to ensure the availability ...
The European Medicines Agency (EMA) has started a review of human papillomavirus (HPV) vaccines to further clarify aspects ...
The Health and Food Safety Directorate-General of the European Commission has launched a call for expressions of interest ...
Senior leaders from the US Food and Drug Administration (FDA), the European Commission,and the European Medicines Agency ...
The European Medicines Agency (EMA) has announced a new logo system in the European Union (EU) to identify legally operating ...
he European Medicines Agency (EMA) has started to publish the outcomes of single assessments of periodic safety update reports ...
The US Food and Drug Administration (FDA) has issued final guidance, Allowable Excess Volume and Labeled Vial Fill Size ...
The US Food and Drug Administration (FDA) has issued final guidance, DSCSA Implementation: Product Tracing Requirements ...
The European Medicines Verification Organization (EMVO) is a Luxembourgish non-profit organization representing stakeholder ...
The Biotechnology Industry Organization (BIO) announced that it will change the name of the organization to the Biotechnology ...
The National Institutes of Health (NIH) has submitted interim corrective action plans to the US Food and Drug Administration ...
The International Conference on Harmonization (ICH) reports that the ICH Q7 Questions and Answers on Good Manufacturing ...
The US Food and Drug Administration (FDA) has issued final guidance, Naming of Drug Products Containing Salt Drug Substances, ...
The US Food and Drug Administration (FDA) has issued final guidance, Size, Shape, and Other Physical Attributes of Generic ...
The European Medicines Agency (EMA) has launched an initiative that offers free-of-charge early pediatric interaction meetings ...
The European Federation of Pharmaceutical Industries and Associations (EFPIA) issued support for data protection reform ...
The European Medicines Agency (EMA) Management Board gave its green light for the central repository for periodic safety ...
The European Medicines Agency (EMA) will hold a webinar on Wednesday June 24, 2015, to update stakeholders on the implementation ...
The National Institutes of Health (NIH) has suspended production of sterile materials at its operations at the Pharmaceutical ...
The US Food and Drug Administration (FDA) has issued final guidance, ANDA Submissions–Refuse-to-Receive Standards: Guidance ...
The US Food and Drug Administration (FDA) has issued final guidance, M7 Assessment and Control of DNA Reactive (Mutagenic) ...
The US Food and Drug Administration (FDA) has issued draft guidance to address the lack of clarity with respect to what ...
The European Medicines Agency (EMA) has issued an update of the European Union (EU) recommendations for the influenza virus ...
The European Medicines Agency (EMA) has confirmed its recommendation to suspend a number of medicines for which authorization ...
The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the China Pharmaceutical Industry Association ...
The European Medicines Agency (EMA) has published the list of active substances and a reference to the journals that will ...
As part of its overall efforts to address compounded drugs, the US Food and Drug Administration (FDA) today released a draft ...
A coalition of 11 companies involved in the development and manufacturing of biopharmaceuticals and “biosimilar” medicines ...
The US Food and Drug Administration (FDA) has issued three final guidances on biosimilars. The final guidances are: Biosimilars: ...
The US Food and Drug Administration (FDA) has issued draft guidance, Waiver of In Vivo Bioavailability and Bioequivalence ...
The US Food and Drug Administration (FDA) has issued final guidance, Pr oviding Regulatory Submissions in Electronic Format—Certain ...
The European Medicines Agency (EMA) issued an annual report to highlight the agency's progress in 2014 in advancing key ...
The US Food and Drug Administration (FDA) has issued a proposed rule requesting additional scientific data to support the ...
Three articles co-authored by researchers at the US Pharmacopeial Convention (USP) were published in a supplement to the ...
The Generic Pharmaceutical Association (GPhA) has launched the Biosimilars Council, a division of GPhA. "The Biosimilars ...
Kenneth C. Frazier, chairman and chief executive officer (CEO) of Merck & Co., Inc., has been elected chairman of the board ...
Health Canada, the national pharmaceutical regulatory agency of Canada, has launched the Drug and Health Product Inspections ...
The board of the European Biopharmaceutical Enterprises, a specialized group with the European Federation of Pharmaceutical ...
The National Coordinating Council for Medication Error Reporting and Prevention has created an Adverse Drug Event (ADE) ...
Former US Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg has been appointed as the next foreign secretary ...
The US Food and Drug Administration (FDA) has issued draft guidance, Risk Evaluation and Mitigation Strategies: Modifications ...
The Generic Pharmaceutical Association (GPhA) issued its support of public meeting held by the US Food and Drug Administration ...
The European Generic and Biosimilar medicines Association (EGA) supported a new French national action plan to promote generic ...
The European Medicines Agency's Enpr-EMA, a network of research networks, investigators and centers with expertise in performing ...
The International Pharmaceutical Excipients Council (IPEC)-Americas has issued a position paper, Implementation of the NSF/IPEC/ANSI ...
The Canadian Generic Pharmaceutical Association (CGPA) has established a new CGPA Biosimilars Board and elected Michel Robidoux, ...
The Canadian Generic Pharmaceutical Association (CGPA) has elected Jeff Watson, president of global generics at Apotex, ...
The United States Pharmacopeial Convention (USP) has announced the establishment of an implementation date of January 1, ...
As previously announced, Dr. Stephen Ostroff, MD,became the US Food and Drug Administration's Acting Commissioner of Food ...
The US Food and Drug Administration (FDA) has issued draft guidance to provide recommendations to applicants of new drug ...
The US Food and Drug Administration (FDA) issued a final guidance to assist industry in developing opioid drug products ...
Fees payable to the European Medicines Agency (EMA) by applicants and marketing-authorization holders decreased by 0.1%, ...
The United States Pharmacopeial Convention announced that Bingbing Feng will become Vice President and General Manager of ...
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have released the "EU Medicines Agencies Network ...
The European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Generic medicines Agency (EGA), ...
The European Generic medicines Association (EGA), an industry association representing generic drug and biosimilar industries, ...
Richard Bergström, EFPIA Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA), ...
The European Directorate for the Quality of Medicines and Health Care (EDQM), which is responsible for the European Pharmacopoeia ...
The European Directorate for the Quality of Medicines and HealthCare (EDQM), which is responsible for the European Pharmacopoeia ...
Health Canada, the national regulatory authority of Canada, has advised drug establishment license holders that it will ...
The US Food and Drug Administration (FDA) has launched the agency’s first mobile application (app) specifically designed ...
Following the recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...
The European Medicines Agency (EMA) reminds applicants and marketing-authorization holders that adjusted fees will be coming ...
The European Medicines Agency (EMA) is establishing a task force for the implementation of international standards for the ...