Showing 15 posts of 1340 posts found.

FDA process validation guidelines emphasise risk management

February 1, 2011
Manufacturing and Production FDA, ICH, process validation

The FDA has published the final version of its Guideline on Process Validation, more than two years after the first …

Sanofi-Aventis' Multaq (dronedarone)

FDA issues Multaq liver warning

January 17, 2011
Sales and Marketing FDA, Multaq, atrial fibrilation, dronedarone

US regulators have warned doctors and patients about the risk of severe liver injury associated with Sanofi-Aventis’ atrial fibrillation (AF) …

Food and Drug Administration (FDA)

FDA launches online transparency initiative

January 11, 2011
Medical Communications, Research and Development, Sales and Marketing FDA, Joshua Sharfstein, transparency

The FDA has launched a new online resource to increase the transparency of its processes and help save companies time …

More US recalls as bill seeks greater FDA powers

January 10, 2011
Manufacturing and Production Centocor Ortho Biotech, Cumberland Pharmaceuticals, FDA, RiteDose Corp, Sandoz, Sigma-tau Pharmasource, Teva Pharmaceuticals, manufacturing compliance, recalls

Product recalls continue to make headlines in the pharmaceutical sector, with several new incidents either side of the New Year …

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Digital Pharma: FDA delays social media guidance until 2011

December 22, 2010
Medical Communications Digital Pharma blog, FDA, social media

The FDA will release its hotly-anticipated social media guidance for pharma companies in a piecemeal fashion, beginning in the first …

Roche to challenge FDA on Avastin

December 21, 2010
Sales and Marketing EMA, FDA, Roche, avastin, bevacizumab, breast cancer

Roche is set to challenge the decision by the FDA to remove a breast cancer indication from its blockbuster drug …

Congressman says FDA should scrutinise J&J’s manufacturing partners

December 21, 2010
Manufacturing and Production BestSweet, FDA, J&J, JJ, Johnson & Johnson, McNeil, Rolaids, manufacturing compliance, recalls

The latest flurry of recalls from Johnson & Johnson has prompted additional calls for a wide-ranging investigation of the company’s …

CP Pharma gets FDA warning for Wrexham facility

November 18, 2010
Manufacturing and Production CP Pharmaceuticals, FDA, FDA warning letter, Wockhardt, manufacturing compliance, pharma manufacturing

UK drugmaker CP Pharmaceuticals is the latest to receive a warning letter from the FDA for failing to meet standards …

FDA approves Eisai breast cancer drug Halaven

November 16, 2010
Sales and Marketing Cancer, Eisai, FDA, Halaven, Xeloda, breast cancer, eribulin mesylate, metastatic breast cancer

The FDA has approved Eisai’s advanced breast cancer drug Halaven for use in heavily pre-treated breast cancer patients. Halaven (eribulin …

FDA slaps import ban on Claris Life Sciences

November 16, 2010
Manufacturing and Production Ahmedabad, Claris Life Sciences, FDA, GMP, GMP violations, Good Manufacturing Practice, Ranbaxy Pharmaceuticals, manufacturing compliance

Indian drugmaker Claris Life Sciences has been prohibited from importing products into the US after manufacturing quality problems emerged at …

Tylenol recall warrants thorough, public investigation, says ISMP

November 15, 2010
Manufacturing and Production FDA, ISMP, Institute for Safe Medication Practices, Johnson & Jonson, MedWatch, Tylenol, Tylenol recall

Johnson & Jonson’s recall of Tylenol painkiller products was one of the key safety trends identified in the last quarter …

FDA approves Merck’s HIV fat drug Egrifta

November 12, 2010
Research and Development, Sales and Marketing EMD Serono, Egrifta, FDA, HIV, Merck KGaA, abdominal fat in HIV, tesamorelin

US regulatory authorities have approved the first treatment indicated to target abdominal fat in patients with HIV after trials showed …

Pfizer enters drug repositioning collaboration with Biovista

November 11, 2010
Research and Development Biovista, FDA, Neurontin, Pfizer, Pfizer Indications Discovery Unit, drug repositioning, viagra

Pfizer has signed a pilot research agreement with drug repositioning specialist Biovista. The aim of the collaboration is to identify …

Sanofi’s C diff vaccine fast tracked by FDA

November 10, 2010
Research and Development C diff, C diff vaccine, C difficile, Clostridium difficile, FDA, FDA fast-track, Sanofi, Sanofi Pasteur

A new vaccine aimed at preventing C difficile infections has been fast tracked by the FDA. The regulator’s decision signals …

Advanced melanoma

BMS skin cancer drug hits US regulatory delay

November 3, 2010
Research and Development BMS, Bristol-Myers Squibb, FDA, MDX010-020 trial, ipilimumab, skin cancer

US regulators have announced they need more time to assess Bristol-Myers Squibb’s skin cancer treatment ipilimumab. The FDA will not …

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