Drugs

Coalition Letter to Energy and commerce Committee on FDA Amendments act H.R. 7667

Representative_____ Energy and Commerce U.S. House of Representatives Washington, DC Dear Representative______,...

Public Comments on FDA's Medical Devices Commitment letter

We would like to express our substantial concerns with the overall process as well as the shortcomings...

Coalition Letter to FDA regarding transparency of the MDUFA V reauthorization process

We write today to follow up on your response to several requests for information at the Food and Drug...

Coalition Letter to FDA and CDRH regarding MDUFA Reauthorization

As key stakeholders, we strongly urge the FDA to hold firm in the demands to strengthen pre- and post-market...

Public Comments to CMS on Aduhelm for the Treatment of Alzheimer’s Disease

We strongly support the CMS proposed decision to limit the coverage of these drugs to patients participating...

Public Comments on FDA's Generic Drugs Commitment Letter

We believe that the proposed recommendations must do more to ensure that generic drugs are providing...

Public Comments on the Reauthorization of the Prescription Drug User Fee Act

We appreciate the opportunity to review the Commitment Letter for PDUFA VII upon conclusion of these...

Patient and Consumer Stakeholder Consultation Meeting, MDUFA V Reauthorization

It is vitally important that the treatments approved by the FDA are proven to be both safe and effective...

Coalition Letter to FDA Regarding UDI Numbers on Medical Devices

We request that the FDA reverse its policy to exempt many implantable medical devices from directly displaying...

Letter to Congresswoman DeGette Expressing Concerns About 21st Century Cures

At the recent E&C Subcommittee on Health markup of the 21st Century Cures Act, Committee Ranking Member...

February 10, 2022

Public Comments to CMS on Aduhelm for the treatment of Alzheimer’s disease

Patient, Consumer, and Public Health Coalition provides public comments on Aduhelm and similar medical products for the treatment of Alzheimer’s disease