FDA regulation news from FiercePharma
NewsFDA halts eye wash and skin cream
The FDA came down on a group of companies that it says is marketing prescription medications without approval. The medications are topical skin creams and eyewashes. One is a skin cream containing a... Read more...
FDA names 20 drugs in safety probes
In a move sure to cause controversy, the FDA will let some sunshine in on its investigations of adverse event reports. Every quarter, the agency will release a list of drugs under investigation... Read more...
Will FDA label regs shield pharma?
The draft rules on labeling updates are now a reality. Next month, regulations about safety warnings will take effect, aimed at offering clarity for drugmakers and increased confidence among... Read more...
FDA to revamp rules on kids' cold meds
Remember all the brouhaha last fall about children's cold medicines? Well, the controversy is back. And... Read more...
FDA might mandate drug training
Perhaps triplicate prescriptions are not enough of a safety measure when it comes to powerful narcotics. At least, that's what the FDA might be thinking. The agency is considering mandatory training... Read more...
Are black box warnings inevitable?
A sociologist and health policy researcher has some stern language for drugmakers and their regulators. "Drug disasters are literally built into the current system of drug testing and approvals in... Read more...
Marketing lessons from FDA warnings
The FDA's marketing regulators have either been pulling their punches lately or drugmakers are complying with promo rules better than usual, because the number of warning letters about advertising... Read more...
House votes to treat tobacco as a drug
If the U.S. House gets its way, the FDA soon may have even more power -- to regulate tobacco as a drug. Reps voted overwhelmingly to charge the agency with overseeing the tobacco industry, in spite... Read more...
SPOTLIGHT: FDA forces contract manufacturer to reform
Contract manufacturer Scientific Laboratories is in a world of hurt today, as FDA has barred it from manufacturing or distributing... Read more...
Pharma drags feet on promised studies
We once saw a sign in a newsroom that said, "Deadlines, schmedlines, as long as I get paid." Maybe Big Pharma has similar signage posted at its various HQs. According to newly released FDA... Read more...
| Press ReleasesPRESS RELEASE: FDA MedWatch - Desmopressin Acetate FDA MedWatch - Desmopressin Acetate - Product Labeling Updated To Include Important New Information About Severe Hyponatremia And Seizures ROCKVILLE, Md., Dec.4, 2007-- FDA notified healthcare Read more >> PRESS RELEASE: EXACT Sciences Corporation Says Gets Warning Letter from FDA EXACT Sciences Corporation Says Gets Warning Letter from FDA MARLBOROUGH, Mass. -- EXACT Sciences Corporation announced today that it has received a Warning Letter from the Food and Drug Read more >> PRESS RELEASE: Warning Letter on Cymbalta Michele Sharp, Pharm.D. Manager, U.S. Regulatory Affairs Eli Lilly and Company Lilly Technology Center Indianapolis, IN 46221 Re: NDA # 21-733 CYMBALTA® (duloxetine hydrochloride) Delayed-release Read more >> PRESS RELEASE: FDA Warning letter to Genzyme Henri A. Termeer Chairman, President and CEO Genzyme Corporation 500 Kendall Street Cambridge, MA 02142 USA Dear Mr. Termeer: The Food and Drug Administration (FDA) conducted an inspection of Read more >> PRESS RELEASE: NPS Pharmaceuticals PREOS Granted U.S. Orphan Drug Status for Treatment of Hypoparathyroidism NPS Pharmaceuticals PREOS Granted U.S. Orphan Drug Status for Treatment of Hypoparathyroidism PARSIPPANY, N.J., Sept. 19 -- NPS Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Read more >> |
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