HITTING THE HEADLINES
FDA Issues Draft Guidance on Electronic Submissions
FDA has issued a draft guidance, Guidance for Industry: Providing Submissions in Electronic Format—Summary Level Clinical Site Data for CDER's Inspection
Planning, which is one in a series of documents intended to assist sponsors and applicants making certain regulatory submissions to
FDA in electronic format.
US Supreme Court to Hear Pay-for-Delay Case
The US Supreme Court agreed to hear a case that will decide whether brand-name drug companies may pay generic drug-companies
to delay introduction of lower-cost generic drugs. The Supreme Court is to review a federal appeals court ruling that upheld
a "pay-for-delay" arrangement.
Ranbaxy Recalls Atorvastatin Due to Quality Issues
Ranbaxy Pharmaceuticals is recalling certain lots of its atorvastatin tablets because of possible contamination with small
glass particles (less than 1 mm in size). Ranbaxy has ceased atorvastatin manufacturing until it has thoroughly investigated
- Valeant Pharmaceuticals International has completed its acquisition of Medicis Pharmaceutical.
- Isochem has expanded its range of intermediates by acquiring the British fine-chemicals company, Wychem.
- French contract manufacturing firm Synerlab has acquired lyophilization specialist company Lyofal.
- Amgen has agreed to buy Icelandic-based Decode Genetics for $415 million in an all-cash transaction.
PharmTech is seeking reader input for a future feature on parenteral drug manufacturing. Send your questions and thoughts to the Community
Manager, Stephanie Sutton, at
READERS THINK THAT...
Take part in our latest poll at: PharmTech.com/Polls
ON THE BLOG
"Real-time devices for continuous feeding processes were discussed at a seminar I recently attended."
See more posts at
- Pharma companies using new analytical methods to ensure quality of medicine ht.ly/g0oIm
- How to optimize continuous processing and make it work in pharmaceutical manufacturing is a crucial issue. ht.ly/g4AtD