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FDA

Showing 15 posts of 1442 posts found.

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FDA refuses to file Eisai’s epilepsy drug

August 1, 2011
Sales and Marketing Eisai, FDA, epilepsy

The FDA has refused to file Eisai’s epilepsy drug perampanel, saying it needs more information for the treatment. The FDA …

News

FDA sets aside $700,000 for manufacturing research

July 25, 2011
Manufacturing and Production FDA, pharma manufacturing news

The FDA has set aside $700,000 to help fund research that “improves reliability of pharmaceutical product manufacturing and quality across …

News
US Food and Drug Administration

Pharma regulators consult on drug development initiatives

July 13, 2011
Research and Development Companion Diagnostics, EMA, FDA, Pharmacogenomics, biomarkers, research and development news

Pharma regulators in the US and Europe have put out separate consultations on issues affecting how medicines are developed. The …

News
Roche's Avastin (bevacizumab)

FDA advisers reject Avastin appeal

June 30, 2011
Sales and Marketing FDA, avastin

An FDA advisory panel has refused to back Roche’s Avastin in advanced breast cancer after ruling it neither safe nor …

News

FDA looks to make drugs risks clearer for patients

June 22, 2011
Medical Communications FDA, advertising

Potential side effects from medicines need to be presented more clearly on prescription drug advertising so patients can understand the …

News
Pfizer

FDA approves Pfizer pain drug Oxecta

June 21, 2011
Sales and Marketing FDA, Oxecta, Pfizer, chronic pain

The FDA has approved Pfizer and Acura’s novel pain drug Oxecta, but will require follow up studies to prove its …

News

Pfizer project is quality-by-design milestone for FDA and EMA

June 21, 2011
Manufacturing and Production EMA, FDA, Quality by Design, pharma manufacturing news

A pilot project set up earlier this year to encourage the adoption of quality-by-design in pharmaceutical manufacturing has passed its …

News

Dr Reddy’s API plant in Mexico under FDA scrutiny

June 21, 2011
Manufacturing and Production APIs, Dr Reddy's, FDA, GMP violations, pharma manufacturing news

Indian drugmaker Dr Reddy’s Laboratories has been sent a warning letter by the US FDA after a manufacturing facility in …

News

Europe slower than US to approve new cancer drugs

June 17, 2011
Sales and Marketing EMA, FDA, FDA approvals, new drug approvals

The European Medicines Agency approves fewer new oncology drugs than its US counterpart and takes nearly twice as long to …

News

FDA plea for notice on drug shortages

June 14, 2011
Manufacturing and Production FDA, pharma manufacturing

The FDA has asked US drugmakers to give advance warning of production problems which could lead to shortages in available …

News

Merck redesigns drug labels for clarity

June 14, 2011
Manufacturing and Production FDA, Labelling, Merck & Co

The FDA has approved a major overhaul of labelling for a range of Merck & Co products, paving the way …

News

FDA goes public with enforcement actions

June 2, 2011
Manufacturing and Production FDA, transparency

The FDA is to publish more details about inspections and court actions on its website as part of a drive …

News

J&J and Vertex’s hep C drug Incivek approved by FDA

May 24, 2011
Sales and Marketing FDA, Incivek, Johnson & Johnson, Vertex, hepatitis C, telaprevir

The FDA has approved Johnson & Johnson/Vertex’s new oral hepatitis C drug Incivek. Incivek (telaprevir), a protease inhibitor, is now …

News

Shire promotional magnet attracts FDA wrath

May 20, 2011
Medical Communications, Sales and Marketing FDA, Shire

The use of a promotional magnet by marketers at Shire has attracted trouble from the FDA. The magnet, which is …

News

Generic and API firms get latest crop of FDA warning letters

May 10, 2011
Manufacturing and Production Cephazone, FDA, FDA warning letter, Ningbo Smart, Teva

Generic drugmakers Teva and Cephazone and API producer Ningbo Smart are the latest companies to receive warning letters from the …

News
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