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Panel to Discuss Dynavax Hepatitis B Vaccine

[ Price : $8.95]

Federal Register Notice: FDA plans a meeting of the Vaccines and Related Biological Products Advisory Committee 11/16 to discuss a...

FDA Plans Small Business Device/Drug Education Conference

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Federal Register Notice: CDER and CDRH plan a conference 9/27-28 entitled: FDA Small Business and Industry Assistance Regulatory E...

Panel to Discuss 2 NDAs for Pneumonia

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Federal Register Notice: FDA plans a meeting of the Antimicrobial Drugs Advisory Committee 11/4 to discuss two Cempra Pharmaceutic...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Amniotic Therapies, Browns Compounding Center, Central Admixture Pharmacy Servic...

FDA Approves Sandoz Biosimilar for Enbrel Copy

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FDA approves a Sandoz BLA for Erelzi, (etanercept-szzs) a biosimilar copy of Amgens Enbrel (etanercept).

FDA Accepts CSL Behring BLA for Hereditary Angioedema Attacks

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FDA accepts for review a CSL Behring BLA for its low-volume subcutaneous CSL830 (C1-esterase inhibitor (C1-INH) human) replacement...

FDA Finalizes Rule to Require Electronic Drug Registration/Listing

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FDA posts a final rule that requires drug/biologic makers to electronically submit, unless waived in certain circumstances, their ...

Guidance on BE Recommendations for Risperidone

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Federal Register Notice: FDA releases a revised draft guidance: Bioequivalence Recommendations for Risperidone.

Commerce Committee Asks FDA How to Expedite EpiPen Generics

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House Energy and Commerce Committee leaders write FDA asking for details on what the agency can do to expedite generic copies of M...

FDA Guidance on Enforcement Discretion on Device Codes

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FDA posts a final guidance on Enforcement Policy on National Health Related Item Code and National Drug Code Numbers Assigned to D...