Blogs about: Fdaaa

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REMS and Generics -- Like Oil and Water

Jeremy G wrote 3 weeks ago: A great post from Michael McCaughan at the In Vivo Blog walks through the very complicated interacti … more →

Tags: Jeremy Grushcow, dr reddys, FDA Amendments Act, Generics, In Vivo Blog, rem's, revlimid, Risk Evaluation and Mitigation Strategies

Disclosure, Disclosure, Disclosure

Jeremy G wrote 3 months ago: Disclosure issues have permeated the news lately.  Pharmaceutical companies need to do a better job … more →

Tags: Jeremy Grushcow, American Psychiatric Association, Clinical Trials, ClinicalTrials.gov, Disclosure, GlaxoSmithKline, GSK, symposium funding

US FDA approvals in 2008 totaled 21 new molecular entities (NMEs)

tristar3research wrote 5 months ago: Specialty products continued to dominate new drug and biologic approvals in the US in a year in whic … more →

Tags: Business Intelligence, bla, CDER, Economy, FDA, Infrastructure, NME, PDUFA, specialty pharmaceuticals

Risk Evaluation and Mitigation Strategy (REMS) for Certain Drugs and Biologics 2 comments

abhishekkatiyar wrote 10 months ago: The U.S. Food and Drug Administration has identified 25 drugs and biologic products that will be req … more →

Tags: Keep updated, Regulatory Affairs, FDA, fda news, Food and Drug Administration Amendments Act of 2007, rem's, Risk Evaluation and Mitigation Strategy (REMS)

What you should know about FDAAA 2007!

KHOI wrote 1 year ago: On September 27, 2007, President Bush signed the Food and Drug Administration Amendment Act of 2007 … more →

Tags: health, Investments, FDA, bush, Amendment, A.C.T., 2007, FDCA, NDA


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