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The FDA wants to make it easier for generics firms to acquire samples from brandmakers who claim drug safety protocols prevent them from selling the products for bioequivalence testing. Read More
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
Sponsors of multi-site clinical trials should take greater advantage of their ability to use a single institutional review board, says a draft policy that seeks to require the practice for all NIH-supported domestic trial sites. 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 is requiring drugmakers to revamp their product labeling to include clearer information on the safe use of drugs and biologicals in pregnant women and nursing mothers, marking the first labeling requirement of its kind since the late 1970s. Read More
Compounding pharmacies are warning that a federal drug safety law is starting to hamper their ability to supply needed therapies to patients, and that a strict reading of the law could cause even greater hurdles to producing the products. Read More
The FDA is considering a new inspection scoring system that would for the first time recognize drugmakers that go beyond normal compliance with good manufacturing practices. Read More