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Manufacturers of prescription and over-the-counter drugs containing acetaminophen should warn patients about the risk of serious skin reactions, according to an FDA draft guidance. Read More
Drugmakers may soon have to report to the FDA how they decide when to launch a CAPA investigation, if they have a performance index for their product’s critical quality attributes and the seniority level of the employee who signs off on the annual product review. Read More
King Pharmaceuticals received a Form 483 after agency investigators discovered problems with damaged equipment and cleanroom suits filled with holes. 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
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
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