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FDA

Showing 15 posts of 1442 posts found.

Teva’s Irvine facility gets FDA green light

May 3, 2011
Manufacturing and Production FDA, Teva, manufacturing compliance

Teva Pharmaceutical Industries has said that an injectables facility in the USA, shut down last April after quality control problems, …

News

FDA issues guidance on preventing antibiotic cross-contamination

April 19, 2011
Manufacturing and Production FDA, GMP, pharma manufacturing

The FDA has published a new guidance document to help drugmakers prevent cross-contamination of pharmaceuticals with non-penicillin beta-lactam antibiotics. The …

News

FDA issues guidance on glass contamination

March 29, 2011
Manufacturing and Production FDA, GMP, glass contamination

The FDA has issued an advisory to pharmaceutical manufacturers on the topic of contamination with thin glass fragments – or …

News

Dendreon wins green light for Provenge production

March 22, 2011
Manufacturing and Production Cancer, Dendreon, FDA, Provenge, pharma manufacturing, prostate cancer vaccine, sipuleucel-T

US oncology specialist Dendreon has been boosted by the approval of additional production capacity for its therapeutic prostate cancer vaccine …

News

FDA and EMA join forces on quality-by-design

March 22, 2011
Manufacturing and Production EMA, FDA, QbD, Quality by Design, pharmaceutical marketing applications

The FDA has teamed up with the EMA on a new pilot programme that will allow parallel evaluation of marketing …

News
EMD Serono headquarters

FDA knocks back Merck KGaA’s oral MS drug

March 2, 2011
Sales and Marketing Cladribine, EMD Serono, FDA, MS, Merck KGaA, Movectro, multiple sclerosis, oral MS drugs

US authorities have turned down Merck KGaA’s new drug application for its oral relapsing-remitting multiple sclerosis treatment Movectro. The FDA …

News
Obama

Obama’s generics plan criticised

February 15, 2011
Sales and Marketing FDA, Obama, PhRMA, generics, reform

US pharma says new plans to end ‘pay-for-delay’ generics deals and shave five years from biologics exclusivity will threaten innovation …

News

R&D productivity worse than previously reported

February 15, 2011
Manufacturing and Production, Research and Development, Sales and Marketing BIO, BMT, FDA, R&D

A new analysis of pharma’s R&D pipelines suggests the overall success rate for drugs moving from clinical trials to FDA …

News
AstraZeneca's social media white paper

Digital Pharma: AZ presses the case for social media in pharma

February 11, 2011
Medical Communications AZ, AstraZeneca, Digital Pharma blog, FDA, social media

Seemingly fed up with waiting for the FDA’s delayed social media guidance, AstraZeneca has published details of its own feedback …

News

Teva plant in Israel cited by FDA, expands in Americas

February 8, 2011
Manufacturing and Production Corporacion Infarmasa, FDA, Peru, Teva, Teva Pharmaceutical, generics, generics manufacturing, manufacturing compliance

A manufacturing facility in Jerusalem operated by Teva Pharmaceutical failed to pass muster in an FDA inspection, prompting a warning …

News
Roche's Avastin (bevacizumab)

Survey shows doctors support FDA Avastin decision

February 7, 2011
Sales and Marketing FDA, Roche, Sermo, avastin, bevacizumab

A survey of US doctors suggests that a majority support the FDA’s decision to take away Avastin’s licence for use …

News

Bayer’s regorafenib gains orphan status for GIST

February 4, 2011
Research and Development, Sales and Marketing Bayer, FDA, GIST, gastrointestinal stromal tumours, orphan drug, regorafenib

Bayer’s investigational compound regorafenib has been granted orphan drug status for the treatment of patients with gastrointestinal stromal tumours (GIST) …

News

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 …

News
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) …

News
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 …

News
The Gateway to Local Adoption Series

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