On December 23, 2007 a significant change to the postmarketing reporting requirements for drug products goes into effect. Chapter VII, SubChapter H, Section 760 of the Food, Drug, and Cosmetic (FD&C) Act establishes new adverse event reporting requirements which apply to the manufacturers, packers, and distributors whose names appear on the labels of over-the-counter (OTC) or behind-the-counter (BTC) drugs marketed in the United States. Please see links below for reference documents related to these new requirements.
Link to Article
www.fda.gov/cder
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Tuesday, December 18
Adverse Drug Experience Reporting
by
Alex Hsieh on behalf of Professor Henry Wang
on Tue 18 Dec 2007 11:14 PM EST
Excipient market set to change, says report
by
Alex Hsieh on behalf of Professor Henry Wang
on Tue 18 Dec 2007 11:12 PM EST
18/12/2007 - Advances in the pharmaceutical industry are expected to have an impact on pharmaceutical excipients within the next decade, a new report claims.
Link to Article in-pharmatechnologist.com
Chao Centre gets rights to manufacture TB drug
by
Alex Hsieh on behalf of Professor Henry Wang
on Tue 18 Dec 2007 11:11 PM EST
18/12/2007 - Eli Lilly has handed over the manufacturing reins of the antibiotic Seromycin to the Chao Centre for Industrial Pharmacy and Contract Manufacturing.
Link to Article in-pharmatechnologist.com |
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