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Pilot Program on Radiation Sterilization Master Files

[ Price : $8.95]

Federal Register notice: CDRH announces its Radiation Sterilization Master File Pilot Program, a voluntary program for companies t...

Format/Content of OTC Monograph Order Request

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FDA publishes a draft guidance recommending the content and format for submitting OTC monograph order requests to the agency.

Meeting on User Fee Programs Financial Transparency

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Federal Register notice: FDA plans a 6/8 public meeting entitled Financial Transparency and Efficiency of the Prescription Drug Us...

Assessing Adhesion with Transdermal Systems

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FDA publishes a draft guidance recommending the design and conduct of studies evaluating the adhesion performance of a transdermal...

Pragmatica-Lung Study Launches

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The National Cancer Institute helps launch the Pragmatica-Lung Study as part of an effort with FDA to modernize clinical trials.

Omega Packaging CGMP Violations

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FDA warns Totowa, NJ-based Omega Packaging Corp. about CGMP violations in its production of drugs as a contract facility.

Class 3 Device Changes Up Recall Risk: Study

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A JAMA Network Open study from the University of Missouri-Kansas City finds a relationship between Class 3 medical device suppleme...

Vanda Wants Teva Generic Hetlioz Pulled

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Vanda Pharmaceuticals asks FDA to revoke its approval of a Teva ANDA for a generic form of Vandas sleep drug Hetlioz and recall th...

Transdermal Irritation/Sensitization Assessment

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FDA publishes two updated draft guidances with current information on aspects of drug transdermal and topical delivery systems to ...

Both Sides Argue Over Jurisdiction in Abortion Case

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In two appellate briefs, plaintiffs and defendants argue over jurisdiction issues in their legal fight involving the abortion drug...