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Comments Sought on IRB Recordkeeping

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on recordkeeping requirements for institutional review boards.

Comments Extended on Product Application Data Availability

[ Price : $8.95]

Federal Register Notice: FDA extends the comment period on a 6/4 Federal Register notice on the proposed availability of de-identi...

No FDA Product Submissions with Fees Until Budget Passes

[ Price : $8.95]

During the current budget impasse on Capitol Hill and partial government shutdown, FDA says it cannot accept medical product submi...

IDE Early Feasibility Study Guidance

[ Price : $8.95]

FDA issues a guidance on developing and reviewing IDE applications for early feasibility studies of significant risk devices.

Comments Sought on Citizen Petitions Guidance

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on a proposed collection of information contained in a guidance on citizen petitions a...

Drug, Device Violations in Sale of OTC Asthmanefrin

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FDAs Florida District Office warns Nephron Pharmaceuticals that its Asthmanefrin is an unapproved new drug being marketed inapprop...

Multiple QS Violations at German Epflex Firm

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FDA warns Germans Epflex Feinwerktechnik about Quality System Regulation violations in its manufacturing of guidewire devices.

United Therapeutics Backs Actelion Generic Ventavis Petition

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United Therapeutics tells FDA it supports Actelions petition asking that any generic Ventavis be approved with a nebulizer that ha...

Guidance on Early Feasibility Device Studies

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Federal Register Notice: FDA releases a guidance: Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Cl...

Guidance on ANDA Submissions Standards

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Federal Register Notice: FDA releases a draft guidance: ANDA Submissions Refuse-to-Receive Standards.