The US Food and Drug Administration (FDA) has finalized guidance that clarifies how the benefits and risks of a drug or biologic factored into the agency@s decisions on whether to approve a new drug ...
The European Commission on Wednesday published the thrice-delayed draft of the contentious legislation that will reshape the regulation of the pharma sector and set the course of the industry for ...
The European Medicines Agency (EMA) said it recommended approval of more than a hundred new drugs in 2025, of which about 40% were for new active substances that had not previously been authorized in ...
Asia-Pacific Roundup: New Zealand’s Medsafe seeks feedback on planned changes to abbreviated filings
The Medicines and Medical Devices Safety Authority (Medsafe) is holding a consultation on plans to extend the abbreviated procedure for new medicine applications and certain change notifications. @ ...
Kick off the 2026 RAPS Twin Cities Chapter with an evening of learning, networking, and mentorship! The Speed Mentoring Event is designed to connect early-career regulatory professionals with ...
Understanding global regulatory guidelines and requirements for chemistry, manufacturing, and controls (CMC) is crucial in developing cellular and gene therapies (CGTs). While the FDA and the EMA ...
The Medicines and Healthcare products Regulatory Agency (MHRA) has published and updated multiple guidance documents in preparation for changes to the UK@s clinical trial legislation.
The 2025 edition of the Chinese Pharmacopoeia (CPh) of the People@s Republic of China includes systematic revisions and improvements across a range of entries. A key aim of the Chinese Pharmacopoeia ...
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A study of routine good clinical practice (GCP) inspections between 2017 and 2023 found a declining number of Form 483s flagging violations at clinical trial sites and a very low number requiring ...
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The Department of Government Efficiency (DOGE) this week claimed it had canceled 30 leases for US Food and Drug Administration (FDA) facilities nationwide, including a facility in St. Louis, MO, which ...
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