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The FDA has warned contract manufacturer Andersen Pharmaceuticals that labeling for one of its astringent products is not only out of compliance with the OTC monograph for the products, but that batch production records at the firm's Norwich, N.Y., facility are also deficient in four areas.
An Austin, Texas, dietary supplement wholesaler has pleaded guilty to four counts of conspiracy for introducing unapproved drugs into interstate commerce, counterfeiting human growth hormone, possessing controlled substances and distributing them, according to a joint announcement from the FDA and the U.S. Attorney for the Western District of Texas.
The FDA and the HHS Task Force on Drug Importation will convene a public meeting April 14 for industry, the public and other stakeholders to submit comments and information for a study on the feasibility of importing prescription drugs from Canada.
The FDA is proposing a series of new initiatives to encourage drugmakers and academic institutions to collaborate with the agency to remove obstacles along the drug development path so that innovative new products can reach patients as quickly and as inexpensively as possible, the agency said in a report released yesterday.
Public Citizen has filed suit against the FDA, alleging the agency ignored the consumer group’s petition a year ago asking for a ban on the antidepressant drug nefazodone, which is marketed by Bristol-Myers Squibb (BMS) as Serzone.
The FDA has reopened the comment period for a notice on time estimates for collecting information for reporting manufacturing changes on approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs), citing a lack of industry input.
Federal regulators have approved Merck’s acquisition of privately held biotech company Aton Pharma, clearing the way for Merck to re-enter the cancer drug market after a 34-year hiatus.
Sanofi-Synthelabo announced yesterday that it has filed for antitrust clearance from European Commission (E.C.) regulators for its hostile takeover bid for France’s largest drugmaker, Aventis.
In the global race to capture the more than $40 billion worth of brand drugs going off patent over the next few years, India’s generic drugmakers are emerging as significant competitors, according to experts.