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Drugmakers providing postmarket benefit-risk assessments to Health Canada will soon need to follow rigid, standardized guidelines that provide both preapproval and postapproval data about a drug product’s efficacy. 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
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
The EU’s primary biotech lobbying group is pushing back against same-name biosimilars, arguing that physicians would find such a system confusing. Read More
Switzerland’s medicines authority said last month that it will not accept marketing authorization applications for biosimilars of low-molecular-weight heparin products already approved there. Read More
Drugmakers seeking variations to marketing authorizations in the EU will now have a point person assigned to usher their applications through the evaluation process, the European Medicines Agency says. Read More