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Congressional Democrats have struck a compromise allowing drug pricing reform to be included in the $1.75 trillion Build Back Better Act — almost a week after the White House disappointed progressives and left out drug pricing provisions from the package’s framework. Read More
The FDA held a virtual public meeting yesterday to discuss proposed recommendations for the reauthorization of the Biosimilar User Fee Act (BsUFA), the agency’s agreement with regulated industry on reauthorizing user fees for fiscal years 2023 through 2027, and the reception was positive. Read More
The incidence of brain blood clots in one healthcare system increased by almost four times after introduction of the Johnson & Johnson (J&J) COVID-19 vaccine, according to data published in the Nov. 1 issue of the Journal of the American Medical Association. Read More
After a delay in 2020, the FDA has launched its new NextGen Portal for drug manufacturers to use for reporting volume data for drugs and biologics. Read More
A federal judge has ruled that HHS acted incorrectly in warning drugmakers that ending discounts via the 340B Drug Price Program would constitute a violation of the law. Read More
The House of Representatives passed a bill in a bipartisan 368-56 vote on Oct. 19 that aims to promote innovation in continuous manufacturing, which is used to produce drugs more efficiently than the conventional batch production process. Read More
The International Society for Pharmaceutical Engineering (ISPE) has proposed changes to the FDA’s draft guidance on postapproval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization (ICH) for makers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part to a high number of adverse events and recalls associated with contaminated products, the FDA has issued a 21-page draft guidance to help manufacturers control microbiological contamination of their nonsterile drugs (NSDs).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