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Safety Outcomes Committee MAPP Out

[ Price : $8.95]

CDER issues a MAPP on a new Safety Outcomes Trials subcommittee under the Medical Policy Council.

Key Provisions of ClinicalTrials.gov Final Rule

[ Price : $8.95]

Two DLA Piper attorneys outline changes in an HHS final rule expanding the ClinicalTrials.gov database.

AOA Meets with FDA on Opternative Concerns

[ Price : $8.95]

The American Optometric Association says it met with FDA officials to voice concerns about online self-administered vision exams s...

Support for MDUFA 4

[ Price : $8.95]

Four stakeholders voice their support for provisions in the MDUFAS 4 reauthorization agreement.

Annual Report on Postmarketing Requirements

[ Price : $8.95]

Federal Register Notice: FDA posts an annual report on the status of postmarketing requirements and postmarketing commitments.

FDA Names Performance Review Board for Senior Officials Pay

[ Price : $8.95]

Federal Register Notice: FDA announces the names of the members who will serve on its Performance Review Board that will review se...

Comments Sought on Device Fellowship Program Applications

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Federal Register Notice: FDA seeks comments on an information collection extension submitted to OMB related to Applications for Pa...

Guide on Mitigating Risks With Endoscope Irrigation

[ Price : $8.95]

FDA posts a guidance on Mitigating the Risk of Cross-Contamination from Valves and Accessories Used for Irrigation Through Flexibl...

Final Rule on Electronic Filing for Product Imports

[ Price : $8.95]

Federal Register Final Rule: FDA issues a final rule to establish requirements for the electronic filing of entries of FDA-regulat...

FDA Guidance on Drug Periodic Safety Reports

[ Price : $8.95]

FDA releases a guidance on Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evalua...