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The World Health Organization (WHO) has reinstated two generic HIV/AIDS drugs made by Indian drugmaker Cipla to a list of recommended medications for use in developing countries.
The Centers for Medicare & Medicaid Services (CMS) has established 34 regions to administer the prescription drug benefit to encourage drug price competition.
Appearing before a federal appeals court Dec. 6, the FDA defended its policy of granting shared 180-day exclusivity periods to multiple generic firms that are first to challenge different patents on the same drug.
Brand firms are still using an effective tactic to delay competition despite a key provision for the generic drug industry in last year’s Medicare drug benefit, a patent attorney said.
The National Electrical Manufacturers Association (NEMA) adopted a new code of ethics Nov. 30 to address business practices between the association's members and the vendor representatives who market and sell medical imaging equipment.
The FTC has charged three related dietary supplement manufacturers and their corporate officers with producing deceptive direct mail and internet advertisements for weight-loss and erectile-dysfunction products.
The FDA will make substantial changes to and relax some of the requirements of 21 CFR Part 11, but the controversial rule won’t go away, according to a former FDA policymaker.