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Court Protects Drug Company Report Contents

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The Drug and Device Law Blog praises a recent federal court decision protecting some company corporate integrity agreement documen...

Teva Supports 180-Day Exclusivity Dispute Process

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Teva voices support for an FDA public process to address issues relating to 180-exclusivity.

FDA Releases Web Course on CMC Requirements for INDs

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FDA posts a new Web-based training course on Chemistry, Manufacturing, and Controls Perspective of the Investigational New Drug Ap...

Baxter Recalls 1 Lot of Mislabeled Potassium Chloride

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Baxter International recalls one lot of potassium chloride injection 10mEq per 100mL due to a labeling error on the shipping carto...

Transparency Has Gone Downhill at OGD: GPhA

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The Generic Pharmaceutical Association tells FDA that transparency has suffered since CDERs Office of Generic Drugs began operatin...

Sanofi, MyoKardia Collaborate on Cardiomyopathy Therapies

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Sanofi and MyoKardia announce their collaboration to discover and develop first-of-a-kind targeted therapeutics for heritable hear...

OMB OKs Info Collection on Device Informed Consent

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Federal Register Notice: The Office of Management and Budget approves a collection of information on devices and exception from ge...

FDA Submits Collection of Info on NDAs to OMB

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Federal Register Notice: FDA submits to the Office of Management and Budget a proposed collection of information on an application...

FDA Issues Emergency Use Authorization for Ebola Diagnostic

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Federal Register Notice: FDA issues an Emergency Use Authorization for an in vitro diagnostic device for detecting Ebola.

Guidance on ANDAs and Justification of Impurity Limits

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Federal Register Notice: FDA is making available a draft guidance for industry entitled ANDA Submissions Refuse to Receive for La...