FDA
FDA process validation guidelines emphasise risk management
February 1, 2011Manufacturing 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 …
FDA issues Multaq liver warning
January 17, 2011Sales 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) …
FDA launches online transparency initiative
January 11, 2011Medical 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, 2011Manufacturing 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 …
Digital Pharma: FDA delays social media guidance until 2011
December 22, 2010Medical 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, 2010Sales 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, 2010Manufacturing 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, 2010Manufacturing 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, 2010Sales 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, 2010Manufacturing 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, 2010Manufacturing 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, 2010Research 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, 2010Research 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, 2010Research 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 …
BMS skin cancer drug hits US regulatory delay
November 3, 2010Research 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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