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Drugmakers are enthusiastic supporters of the FDA’s plans to offer five years of market exclusivity for more fixed-dose combination products — but they want the agency to broaden its new policy so it will cover products already under review. Read More
The Arkansas Supreme Court declined to hear an appeal of its decision to reverse a $1.2 billion verdict against Johnson & Johnson over the practices the company used to market the antipsychotic Risperdal. Read More
The European Commission is moving toward putting new restrictions on drugs that contain domperidone, removing the EC’s approval of the drugs for treatment of bloating and heartburn due to increased heart risks. Read More
Hospira’s quality struggles continue as the injectable giant voluntarily recalled seven lots of generic anesthetic propofol due a defect that led to metal particles in certain vials. Read More
The European Commission is mandating that drugmakers implement a detailed protocol for transferring testing methodology from one lab to another to ensure product quality. Read More
Glenmark Generics, U.S. subsidiary of India-based Glenmark Pharmaceuticals, has recalled a lot of generic ranitidine 150 mg tablets after a pharmacist complained that one bottle of the drug contained 50 mg metoprolol tartrate tablets instead of the intended drug. Read More
An FDA task force Apr. 22 recommended the agency expand the amount of information about inspections and enforcement that it releases, allowing the public to view a more detailed record of a company’s compliance history. Read More
FDA drug approval times vary widely depending on which division is conducting an application’s review, with approvals for Alzheimer’s and Parkinson’s drugs taking three to four times longer than cancer drugs. Read More
Drugmakers must now give Brazil’s Anvisa a full year’s warning before withdrawing a product from the market if the withdrawal could result in a drug shortage. Read More