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The FDA has sent Kos Pharmaceuticals a warning letter citing quality system deficiencies observed during an inspection of the drugmaker's main manufacturing facility, the company announced Monday.
European trade officials have told several European countries to loosen their importation laws that restrict low-priced drugs from entering their borders — a move that drugmakers argue will hurt their sales.
A New York institutional review board (IRB) may be disqualified if it does not correct several violations cited during a recent FDA inspection, placing all current device research under its oversight in jeopardy.
The FDA is withholding final approval of Staar Surgical’s premarket approval application (PMA) for its implantable contact lens (ICL) while the company implements better procedures for filing medical device reports (MDRs).
Roche is cautioning physicians not to prescribe its popular flu treatment to patients under a year old following recent animal safety trial results, according to a letter released on the FDA’s MedWatch website late Friday.
Eli Lilly has resolved FDA concerns about current GMP issues at its Indianapolis facilities, where it plans to manufacture the antidepressant Cymbalta and injectable schizophrenia drug Zyprexa, the company announced recently.
The FDA is giving a dental laboratory in Costa Rica a final chance to correct several quality system violations cited during a recent inspection before taking further regulatory action.
Promotional materials for Organon's Follistim fertility drug minimized the drug's risks and made unsubstantiated superiority claims, according to an untitled letter released by the FDA late December.
FDA authority will be tested for the first time under the 1994 Dietary Supplement Health and Education Act (DSHEA) in March as the agency girds itself against court challenges from supplement makers when a U.S. ban against ephedra goes into effect.
In its first challenge to ban the sale of a dietary supplement under the 1994 Dietary Supplement Health and Education Act (DSHEA), FDA announced Tuesday it will issue a final rule to prohibit the sale of dietary supplements containing ephedra.