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13 ANDAs Not Withdrawn for S&E

[ Price : $8.95]

Federal Register Notice: FDA determines that 13 ANDAs were not withdrawn from sale for reasons of safety or effectiveness.

FDA Stays Parts of IND Guidance

[ Price : $8.95]

Federal Register Notice: FDA announces a stay of portions of its final guidance: Investigational New Drug Applications Determinin...

Public Workshop on Clinical Trial Safety

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Federal Register Notice: FDA plans a public workshop 12/2: Clinical Trials Assessing Safety and Efficacy in Diverse Populations....

Comments Re-opened on Human Cells Guidance

[ Price : $8.95]

Federal Register Notice: FDA reopens the comment period for the draft guidance on minimal manipulation of human cells, tissues, an...

Hearing on Human Cells Guidances

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Federal Register Notice: FDA will hold a public hearing 4/13/16 on four recent draft guidance on the regulation of human cells, ti...

Comments Re-opened on Surgical Procedure

[ Price : $8.95]

Federal Register Notice: FDA reopens the comment period on a draft guidance: Same Surgical Procedure Exception: Questions and Answ...

Guidance on Progesterone Bioequivalence for ANDAs

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FDA posts a draft guidance on Progesterone Bioequivalence Recommendations that provides the current agency thinking on studies tha...

Quest Recalls Myocardial Protection System Delivery Sets

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Quest Medical recalls its Myocardial Protection System Delivery Sets due to the potential to have intermittent seal failure during...

Pharmacy Group Creates Biosimilars Intelligence Consortium

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The Academy of Managed Care Pharmacy announces the formation of the Biologics & Biosimilars Collective Intelligence Consortium a ...

FDA Stays Part of Guidance on INDs

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FDA says it is staying part of its final guidance on Investigational New Drug ApplicationsDetermining Whether Human Research Studi...