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FDA Issues Draft Guidance on Electronic Submissions
FDA has issued a draft guidance, Guidance for Industry: Providing Submissions in Electronic Format—Summary Level Clinical Site Data for CDER's Inspection Planning, which is one in a series of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.http://PharmTech.com/ElectronicGuidance
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 the problem.
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
ON THE BLOG
"Real-time devices for continuous feeding processes were discussed at a seminar I recently attended."
Jennifer Markarian, http://PharmTech.com/RealTime
See more posts at blog.PharmTech.com