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Draft ICH M7 Guideline Available

[ Price : $8.95]

Federal Register notice: FDA makes available a draft ICH guidance entitled M7(R2)Addendum: Application of the Principles of the IC...

Guide on Hepatitis B Infection Drugs

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Federal Register notice: FDA makes available a final guidance on clinical development recommendations for hepatitis B virus infect...

Bayer Wants 30-Month Stay of Apotex ANDA

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Bayer asks FDA to confirm that it will apply a 30-month stay to an Apotex ANDA for a generic form of Bayers Astelin nasal spray.

FDA Still Has Concerns About Minerva NDA

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Minerva Neurosciences says FDA continues to have questions and concerns about its proposed NDA for roluperidone to treat negative ...

Ways to Expedite Gene Therapy Development: Marks

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CBER director Peter Marks outlines ways in which FDA and other stakeholders could expedite the development of gene therapies.

Hepatitis B Drug Development Guidance

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FDA publishes a guidance to help sponsors develop drugs and biologics to treat chronic hepatitis B virus.

ICH Addendum to M7(R2) Out

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FDA publishes for comment a draft of revisions to the International Council for Harmonization M7 guideline on calculating compound...

Comments on Human Immunogenicity Info Guidance

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Three drug companies comment on an FDA draft guidance on the labeling content and format of immunogenicity information in human pr...

Public Meeting on Device User Fee Reauthorization

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Federal Register notice: FDA announces a 4/19 virtual public meeting entitled Medical Device User Fee Amendments to discuss propos...

Info Collection on PET Drug GMPs

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Federal Register notice: FDA seeks comments on an information collection revision on positron emission tomography drug GMPs.