Pressure Mounting for FDA Commissioner Among Reports that Califf Will Be Biden’s Choice

Pressure Mounting for FDA Commissioner Among Reports that Califf Will Be Biden’s Choice

News sources are reporting that the leading FDA commissioner candidate is someone who had not been widely mentioned -- former FDA Commissioner Dr. Robert Califf...

 

October 21, 2021 2:55 PM
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FDA Issues BsUFA Commitment Letter, to Hold Public Meeting Nov. 2

FDA Issues BsUFA Commitment Letter, to Hold Public Meeting Nov. 2

The FDA will hold a virtual public meeting Nov. 2 to discuss the proposed changes it would like to make during the reauthorization process for the Biosimilar User Fee Act for fiscal years 2023 through 2027...

October 11, 2021 11:26 AM
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Comment Now on FDA Draft Guidance on Use of EHRs, Claims Data as RWD

Comment Now on FDA Draft Guidance on Use of EHRs, Claims Data as RWD

As part of its real-world evidence (RWE) program, the FDA last week issued a draft guidance to provide its current thinking about the use of electronic health records or medical claims data in clinical studies “to support a regulatory decision for effectiveness or safety”...

October 4, 2021 3:11 PM
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FDA, HRA Starting to Address Trial Investigator Result Reporting Lapses

FDA, HRA Starting to Address Trial Investigator Result Reporting Lapses

Sept. 27, 2021 – In the midst of public scrutiny regarding clinical trial transparency, the FDA and the HRA recently took actions that may indicate they will up monitoring of clinical investigators not reporting trial results in a timely manner...

September 27, 2021 6:33 AM
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Recent Posts

OPDP Enforcement Letter to Eton Pharmaceuticals Cites Omission of Risk Info in Sponsored Links

08, 30, 2021

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PhRMA’s Updated Code for Industry Addresses Speaker Programs, Meals

08, 20, 2021

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What Biden’s Drug Pricing Plans Could Mean for Biopharma

08, 16, 2021

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About Us

CHC

CHC

The Coalition for Healthcare Communication is an organization that promotes the free exchange of scientific and medical information. It is essential that healthcare professionals and the general public receive truthful, accurate information regarding pharmaceuticals, medical products and devices, and patient care.

In addition to white papers and other documents published by the Coalition, you can also find relevant information on current healthcare and health economics issues, as well as policy positions published by government agencies and other professional organizations.