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FDA

Showing 15 posts of 1442 posts found.

Shared API inspections project gains traction

October 26, 2010
Manufacturing and Production API, EDQM, EMA, FDA, TGA, manufacturing compliance, pharma manufacturing, regulatory affairs, regulatory inspections

A three-way initiative between regulatory authorities in the EU, US and Australia on the inspection of facilities making active pharmaceutical …

News

Arena’s obesity treatment lorcaserin rejected by FDA

October 25, 2010
Sales and Marketing Arena Pharma, Eisai, FDA, FDA complete response letter, lorcaserin, obesity

A new weight loss drug has been rejected by the FDA because of numerous concerns about side-effects and limited efficacy. …

News

FDA rejects Viropharma’s Cinryze manufacturing expansion

October 25, 2010
Sales and Marketing Cinryze, FDA, FDA complete response letter, Viropharma, angioedema, pharmaceutical manufacturing

ViroPharma was dealt a blow late last week when the FDA turned down its application for additional manufacturing capacity for …

News

FDA warns Gilead over contamination risks at California facility

October 25, 2010
Manufacturing and Production AmBisome, Cayston, FDA, Gilead, Macugen, Viread, manufacturing compliance, pharma manufacturing

Gilead Sciences has been sent a warning letter from the FDA after failing to rectify problems at a facility used to …

News

FDA unveils new trial data rules

October 1, 2010
Research and Development FDA, clinical trials, pharmacovigilance

The FDA has clarified its rules on what safety information must be reported during clinical trials of investigational drugs and …

News

The Food and Drug Administration (FDA)

October 1, 2010
FDA, Food and Drug Administration

The current incarnation of the Food and Drug Administration (FDA) was established in 1930, but the US regulator’s modern functions …

News
FDA director of manufacturing and product quality Rich Friedman

The FDA Interview: Is pharma getting worse at manufacturing?

September 29, 2010
Manufacturing and Production, Research and Development FDA, manufacturing, manufacturing compliance

It seems that barely a week goes by at the moment without news of another pharmaceutical company falling foul of …

Feature

Avandia withdrawn in Europe, but remains in US

September 24, 2010
Sales and Marketing Avandia, FDA, pharmacovigilance, safety

GSK’s diabetes drug Avandia is to be withdrawn from the market in Europe because of high levels of heart attack, …

News

Gilenya approved as new frontline MS treatment

September 22, 2010
Research and Development, Sales and Marketing Cladribine, FDA, Novartis, gilenya

Novartis’ new multiple sclerosis treatment Gilenya has been approved by the FDA, and is set to significantly alter the way …

News

FDA warns BMS over manufacturing plant in Puerto Rico

September 15, 2010
Manufacturing and Production BMS, FDA, GMP, Puerto Rico

A plant operated by Bristol-Myers Squibb in Puerto Rico has been cited by the US Food and Drug Administration for …

News
FDA

FDA already notified on ProAmatine withdrawal, says Shire

August 18, 2010
Sales and Marketing FDA, ProAmatine, Shire

Shire is to withdraw its product ProAmatine following a demand from the FDA early this week regarding post-marketing data on …

News

FDA considers pulling ProAmantine

August 17, 2010
Sales and Marketing FDA, Shire, post-marketing

Shire’s low blood pressure drug ProAmantine and generic copies could be withdrawn from the US market because no post-marketing studies …

News

Bill would give FDA mandatory recall powers

July 27, 2010
Manufacturing and Production FDA, manufacturing compliance, recalls

The chairman of the US congressional committee investigating the quality control problems at Johnson & Johnson, Edolphus Towns, has introduced …

News

FDA draft CMC guidance could cut down on red tape

June 30, 2010
Manufacturing and Production FDA, GMP, manufacturing

The FDA has published draft guidance aimed at alleviating the burden on pharmaceutical companies of notifying the agency of minor …

News

FDA tightens pharma’s responsibility for outsourcing

June 22, 2010
Manufacturing and Production FDA, GMP, manufacturing, outsourcing

Pharmaceutical manufacturers will be held more responsible for the activities of their suppliers and outsourcing partners under a new approach …

News
The Gateway to Local Adoption Series

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