A Colorado dietary supplement manufacturer wrongfully included potentially harmful ephedrine alkaloids in one of its products and made improper claims for drug-like effects from others, the FDA said in a…

The FDA’s draft guidance on post-approval manufacturing changes for biological products needs work to clarify how it fits with previous agency documents, according to written comments on the draft, which…

Health Canada has proposed fee hikes for reviewing applications for approval of new drugs, for oversight of drug manufacturing facilities, for postmarket monitoring of drug sales and for other regulatory…

Finger-pointing abounded Tuesday in a Senate hearing on prescription drugs prices, where branded and generic drug industry representatives testified alongside pharmacist, wholesale distributor and benefit manager groups. Source: Drug Industry…

The European Medicines Agency outlined its thoughts on the use of evidence generated through extrapolation techniques in regulatory assessments, in a draft reflection paper. Source: Drug Industry Daily

A federal judge ruled that Actavis Laboratories infringed on patents held by Orexigen Therapeutics. Source: Drug Industry Daily

A federal judge halted sales by a California company that customizes dietary supplements by name and formulation until the company clears an FDA inspection. Source: Drug Industry Daily

The European Medicines Agency will try to maintain “business as usual” for as long as possible throughout the U.K.’s upcoming exit from the European Union, according to a newly released…

A Texas judge on Monday invalidated the Restasis patents Allergan controversially transferred to a Native American tribe. Source: Drug Industry Daily

The European Medicines Agency’s Committee for Medicinal Products for Human Use had a light meeting load this month, recommending approval for a single generic medicine and expansions of indications for…