Keyword: Food and Drug Administration (FDA)

News

Ending Drug Trial Secrecy Is a Boon for R&D, Says EU Agency

22.10.2013 - Europe's medicines regulator has come out fighting for greater transparency for clinical trials, arguing that its controversial policy to end data secrecy will be "a boon to drug...

News

Roche Breast Cancer Drug Gets U.S. Pre-Surgery Approval

02.10.2013 - U.S. health regulators expanded the approval of Roche's breast cancer drug Perjeta and will now allow its use to help shrink tumors prior to surgery, the FDA said. The decision...

Plant Construction & Process Technology

United in Philosophy and Approach

11.09.2013 - Smooth Connection — Custom manufacturing isn't as easy as filling an order and calling it a day. The gears that interlink a CMO and its customer have to be well oiled and a perfect...

Plant Construction & Process Technology

Enzymes as a Catalytic All Rounder

10.09.2013 - The Perfect Storm - More and more chemical and pharmaceutical companies are recognizing the need to make their processes more environmentally sustainable, a trend that is right at...

Chemistry & Life Sciences

Buyer Beware, Patient Beware

02.07.2013 - On July 2, the Falsified Medicines Directive (FMD) went into full force: All APIs imported into the EU must be accompanied by written confirmations of quality by the regulatory...

News

Probe Indicates Biotech Wheat Was "Isolated Incident"

15.06.2013 - The unapproved genetically modified wheat that was discovered sprouting in Oregon appears to have been "a single isolated incident," U.S. agricultural officials said on Friday in...

News

FDA Panel Votes to Relax Avandia Restrictions

07.06.2013 - U.S. health advisers voted on Thursday to recommend relaxing market restrictions on GlaxoSmithKline's diabetes drug Avandia, the former blockbuster at the center of one of the...

News

U.S. Finds Unapproved Genetically Modified Wheat in Oregon

30.05.2013 - A strain of genetically engineered wheat never approved for sale or consumption was found sprouting on a farm in Oregon, the U.S. government said on Wednesday, and grain traders...