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Manufacturers are urging the FDA to ax three proposed quality metrics related to annual product reviews that would measure a facility’s quality culture, claiming they are too burdensome, unnecessary and confusing. Read More
The FDA this week approved two drugs for rare bone marrow cancers: Amgen’s Blincyto for Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (ALL) and Incyte’s Jakafi for a new indication to treat polycythemia vera. Read More
Brazil is providing more clarity around voluntary public-private partnerships that aim to expand access to affordable drugs, but questions remain about transparency of the program and the division of markets between competing partnerships. Read More
The FDA says it plans soon to release new guidance on complying with product track-and-trace requirements that kick in Jan. 1, but industry says the agency also should strengthen rules that clarify that federal regulations preempt state laws. Read More
The European Medicines Agency said there is no evidence linking Novartis’ influenza vaccine Fluad to a series of adverse events and deaths that prompted Italian officials last month to suspend nearly a half-million doses of the product. Read More
The FDA has warned two Florida-based compounders, one for repeatedly making drugs without a prescription and another for more than 30 adverse events connected to its products. Read More
The FDA has cited Cadila Pharmaceuticals for poor data integrity practices and sloppy investigations into foul smelling batches of active pharmaceutical ingredients (APIs), violations that the agency threatened could result in an import alert. Read More
The FDA has slapped another Indian active pharmaceutical ingredient maker with a warning for data integrity weaknesses, including printing batch records from personal computers over which the company lacked adequate controls. Read More
Drugmakers participating in an ISPE pilot program on quality metrics received new guidance on what data they need to collect, information that could provide a glimpse of the kinds of data that the FDA will start collecting next fall. Read More