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The International Society for Pharmaceutical Engineering (ISPE) has proposed changes to the FDA’s draft guidance on postapproval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization (ICH) for makers of drugs and drug-device combination products. Read More
Due in part to a high number of adverse events and recalls associated with contaminated products, the FDA has issued a 21-page draft guidance to help manufacturers control microbiological contamination of their nonsterile drugs (NSDs). Read More
A primary aim of the consortium is to improve understanding of the basic biology of the adeno-associated virus, a common gene-delivery vector. Read More
Since President Biden abandoned any provisions seeking to reduce prescription drug prices in the approximately $1.75 trillion Build Back Better bill framework unveiled last week, Democratic lawmakers have been trying to resolve internal divisions and put drug pricing reform provisions back into the bill. Read More
The FDA is slated to receive a one-time infusion of $300 million to upgrade its physical and technological infrastructure, according to the updated text of the proposed $1.75 trillion Build Back Better Act released last week. Read More
The FDA on Friday granted an updated Emergency Use Authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine for use in children ages five to 11 years — following a thumbs up from the agency’s expert advisory panel earlier in the week. Read More
The FDA has released its commitment letter for the reauthorization of the Generic Drug User Fee Act (GDUFA), hammered out over several meetings with industry this year. Read More
Under the deal, 105 low- and middle-income countries will gain access to the treatment, following authorization from the World Health Organization and/or national regulators. Read More
Sesen Bio received an FDA warning letter Oct. 27, knocking the company over a 4-year-old personnel issue that came to light in a recent biologics license application (BLA) review of Vicineum for treatment of bladder cancer. Read More