Pharmafile Logo
Pharmafocus logo
Advanced Search

FDA

Showing 15 posts of 1442 posts found.

FDA streamlines GMP for combination products

October 2, 2009
Manufacturing and Production FDA, US, reg

The US Food and Drug Administration has said it will draw up new rules on Good Manufacturing Practices (GMP) for …

News

FDA warns Bayer over German API facility

September 17, 2009
Manufacturing and Production Bayer, FDA, reg

The US regulator has sent a warning letter to Bayer indicating it found "significant deviations from US current good manufacturing …

News

New FDA head aims for aggressive enforcement

August 11, 2009
Research and Development, Sales and Marketing FDA, US, drug safety

The new head of US regulator the FDA has set out a vision to support public health, through tighter laws …

News

TNF blockers must carry children’s cancer warning

August 7, 2009
Research and Development, Sales and Marketing FDA, RA, TNF

The FDA has ruled that TNF blocker drugs should carry new warnings of the increased risk of certain cancers for …

News

FDA blocks Teva from selling vet drugs and warns Apotex

August 6, 2009
Manufacturing and Production Apotex, FDA, Teva

The FDA’s clampdown on quality standards continues apace, with Teva’s animal health unit in Missouri and an Apotex plant in …

News

US approval boosts Plavix competitor

July 14, 2009
Research and Development, Sales and Marketing Effient, FDA, US, lilly

US regulator the FDA has approved Lilly and Daiichi Sankyo's Effient, a rival treatment to the world's best-selling blood-thinning drug …

News

Writing on the wall for ‘pay to delay’ generics deals

July 9, 2009
Research and Development, Sales and Marketing FDA, US, generics

Deals allowing US pharma companies to pay generics competitors to delay the launch of rival products should be ended, according …

News

Genzyme’s woes are a boost for Shire and Protalix

July 9, 2009
Research and Development, Sales and Marketing FDA, Genzyme, US

The contamination problems at a plant used by Genzyme to manufacture a drug for Gaucher disease have prompted the US …

News

Depression warnings for Chantix and Zyban

July 7, 2009
Research and Development, Sales and Marketing Chantix, FDA, US, drug safety

Pfizer and GSK's smoking cessations drugs will have to carry strong warnings of depression and other mental health adverse events …

News

FDA to improve transparency

June 3, 2009
Research and Development FDA, US

The US medicines regulator is to boost the transparency around its decision-making, in connection with President Obama's aim to make …

News

Coast first casualty in US overhaul of IRB system

May 5, 2009
Research and Development FDA, US

A US company offering institutional review board services to sponsors of clinical trials has been forced to close its doors …

News

Sanofi boosted by Multaq vote of approval

March 19, 2009
Research and Development, Sales and Marketing FDA, Multaq, Sanofi, US

An FDA committee has recommended Sanofi-Aventis' new atrial fibrillation treatment Multaq, the company's most important late-stage drug. The FDA cardiovascular …

News

Hamburg appointed as new FDA head

March 18, 2009
Research and Development FDA

A leading public health expert has been appointed as the new head of the FDA. President Obama has selected Dr …

News

Blow for Genzyme as FDA finds fault with Allston facility

March 13, 2009
Research and Development, Sales and Marketing FDA, Genzyme

The chances of approval for Genzyme's new Pompe disease drug Lumizyme have diminished dramatically after the US Food and Drug …

News

FDA finalises transgenic animals guide

January 23, 2009
Research and Development, Sales and Marketing FDA, US, reg

The route map for companies wishing to sell medicines made in genetically-engineered animals has been drawn up by the FDA. …

News
The Gateway to Local Adoption Series

Latest content

Just – Evotec given Gates Foundation grant to increase global biotherapeutics access

January 8, 2026

Johnson & Johnson submits robotic surgical system for De Novo classification

January 8, 2026

EA Pharma announces phase 3 trial for new schizophrenia treatment in Japan

January 7, 2026

Eleva appoints Erich Rajkovic as Chief Business Officer

January 7, 2026

MedPharm announces US FDA inspection of North Carolina manufacturing facility

January 6, 2026