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Several dietary supplements produced by manufacturer Reality Health Research (RHR) are drugs based on the company’s claims that the products prevent and cure a host of diseases, the FDA said in a warning letter.
King Pharmaceuticals has blasted a recent FDA decision allowing generic firms to market versions of King’s muscle relaxant Skelaxin (metaxalone) without labeling that says taking the drug with food increases its bioavailability.
A University of Chicago clinical trial investigator was warned by the FDA for allegedly implanting unapproved cardiac devices in at least eight patients over the course of three years.
Generic firm Andrx’s bid to market a version of McNeil Consumer & Specialty Pharmaceuticals’ attention deficit/hyperactivity disorder (ADHD) drug Concerta could face new hurdles if the FDA accepts McNeil’s argument that additional studies are needed to establish bioequivalency.
In the first collaboration between the private and public sectors in the microbicide field, Johnson & Johnson (J&J) has given its rights to an experimental HIV topical gel product to the International Partnership for Microbicides (IPM), a nonprofit group.
The FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) has issued a warning letter to Wyeth Pharmaceuticals over misleading claims by the firm that its antidepressant Effexor outperforms other popular antidepressant drugs.
The FDA has released an international draft guidance to help makers of biological and biotechnological drugs design studies to assess the comparability of products before and after changes are made to the manufacturing process. Such studies determine whether a manufacturing change adversely affects the quality, safety and efficacy of the product.
The chairman of the Senate Finance Committee has ramped up his investigation into allegations the FDA withheld -- and continues to withhold -- a report that says there may be increased risk of suicide among children taking antidepressant medications, and demanded the agency provide records and make officials available for interviews.
A top FDA official has informed Wisconsin's governor that the state's drug reimportation website violates federal law, and suggested it include an additional disclaimer that pharmaceuticals purchased over the internet from Canada are not necessarily approved by U.S. regulators or safe.