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Home » Topics » Pharmaceuticals » Regulatory Affairs

Regulatory Affairs
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CBER Expands Its 2017 Guidance Agenda

July 5, 2017
CBER added several topics to its guidance agenda for 2017 in its mid-year update, including blood donor requalification and the use of certain serum tests in reducing infection transmission. Read More

Industry Group Petitions FDA to Withdraw Approvals of Non-Abuse-Deterrent Opioids

July 5, 2017
An industry-funded group has petitioned the FDA to fully transition to opioid painkillers with abuse-deterrent labeling, and to require manufacturers to convert their non-deterrent products. Read More

EMA and EUnetHTA Launch Joint Gateway for Parallel Advice

July 5, 2017
The European Medicines Agency and the European Network for Health Technology Assessment have developed a joint platform for parallel consultations on evidence plans for marketing authorizations and health technology assessments to provide sponsors with simultaneous, coordinated advice on development strategies. Read More

FDA Delays Enforcement of Supply Chain Identifier Requirements for One Year

July 5, 2017
The FDA will give manufacturers an extra year before it begins enforcing new requirements for individual serial codes in drug packaging, according to a new draft guidance. Read More
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FDA Taking Comments on BsUFA II Review Assessment Project

July 5, 2017
To accommodate the increased interaction, the FDA said its review clock will begin after a 60-day administrative filing review period. Read More

FDA Delays Enforcement of Supply Chain Identifier Requirements for One Year

July 3, 2017
The FDA will give manufacturers an extra year before it begins enforcing new requirements for individual serial codes in drug packaging, according to a new draft guidance. Read More

FDA Relaxes Medical Gas GMP Compliance Guidance

July 3, 2017
The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing its recommendations on expiration dating and certain warehousing procedures following extensive input from industry. Read More

FDA Relaxes 14-Year-Old Recommendations for Medical Gas GMP Compliance

June 30, 2017
The FDA replaced its 14-year-old draft guidance on cGMPs for the production of medical gases, relaxing some recommendations on expiration dating and warehousing procedures. Read More

FDA Relaxes 14-Year-Old Recommendations for Medical Gas GMP Compliance

June 30, 2017
The previous version, issued in 2003, required that each container bear an expiration date, based on related storage conditions. Read More
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FDA Orphan Products Office to Focus on Clearing Backlog

June 30, 2017
The agency’s plan also includes implementing a new, streamlined template for reviewing orphan designations. Read More

FDA Orphan Products Office to Focus on Clearing Backlog

June 29, 2017
To meet its goals of clearing a backlog of about 200 orphan designation requests before Sept. 21 — and committing to 90-day reviews thereafter — the FDA has formed a “SWAT team” of reviewers dedicated to the task, starting with the oldest applications first. Read More

GAO: Generics Getting Faster Approvals, but FDA Needs Plan to Use Extra GDUFA Funds

June 29, 2017
The agency needs to have a better plan for the funds that are left over at the end of the fiscal year, the GAO said. Read More
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