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New FDA rules could streamline CMC reporting

July 1, 2010 — 6:44am ET | By Tracy Staton

Less red tape, not more? Yes, it's true. The FDA has proposed new rules that would ease the burden of notifying the agency of every single change in manufacturing processes, in-Pharm reports. The... Read more...

FDA regulation Press Releases

FDA Takes Actions on Darvon, Other Pain Medications Containing Propoxyphene
FDA: Boxed Warning on Serious Mental Health Events to be Required for Chantix and Zyban
Merck Statement in Response to FDA's June Communication with Updated Information on Leukotriene Inhibitors, Including Singulair
FDA Requests Labeling Change for Leukotriene Modifiers
Agennix Receives Fast Track Designation From FDA for Talactoferrin in Combination With Sunitinib for Renal Cell Carcinoma a

Latest Headlines

New FDA rules could streamline CMC reporting
July 1, 2010
Rule could let biologics makers use tech tools to ease regulatory burden
May 5, 2010
FDA advises on cargo, warehouse theft prevention and response
April 28, 2010
FDA: GMP games may land execs in jail
March 18, 2010
FDA's Sharfstein talks REMS, track and trace
March 15, 2010
Melamine fines offer cautionary tale
February 10, 2010
FDA preps to toughen up
August 10, 2009
Hamburg pushes toward "strong FDA"
August 10, 2009

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