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House Lawmakers Query FDA on Device Cybersecurity

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House Energy and Commerce Committee members Diana DeGette (D-CO) and Susan Brooks (R-IN) ask FDA for information about how it is w...

CDER Hires ex-Merck Exec as New Drugs Deputy

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FDA hires former Merck executive Peter Stein to serve as CDER Office of New Drugs deputy director effective 11/14.

Fix Drug Approval Announcement Non-system: Attorneys

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Hyman, Phelps and McNamara attorneys say FDA must fix its broken system of announcing complex decisions on questions arising at th...

Dont Drop Off-Label Marketing Enforcement: Law Professors

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Two Yale law school professors say FDA should staunchly defend its current regulatory regime restricting company promotion of off-...

Issues Raised on 510(k) Change Guidance

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Five stakeholders raise concerns about an FDA draft guidance on when a new 510(k) should be submitted for a change to an existing ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Innovative Compounding Pharmacy and Valeant Pharmaceuticals.

Final Rule to Reflect Agency Organization Change

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Federal Register Final Rule: FDA issues a final rule to amend the regulations to reflect organization change in the agency and to ...

Comments Sought on Standardized Study Data Template

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Federal Register Notice: FDA establishes a public docket to collect comments related to a proposed Study Data Standardization Plan...

Clinical Hold Slapped on BioInvent Myeloma Drug

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FDA places a clinical hold on a BioInvent International Phase 2 study of the antibody BI-505 in patients with multiple myeloma.

QS Violations Found in Valeant Inspection

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FDAs New York District Office warns Valeant Pharmaceuticals about Quality System regulation problems in its development of specifi...