CHPA looks forward to working closely with FDA and other key stakeholders throughout the OMUFA reauthorization process as we work together to ensure the continued success of FDA’s OTC monograph program.
Comments regarding Citizen Petition from Greenberg Traurig requesting that FDA issue the administrative order for OTC external analgesics, and that FDA confirm and clarify for which specific indications OTC external analgesic drug products in patch/plaster/poultice dosage forms are generally recognized as safe and effective.
House and Senate negotiators are at odds over how to move forward with the FDA user fee reauthorization now that Senate HELP Committee Ranking Member, Senator Richard Burr (R-N.C.) is pushing a significantly pared-down version of the user fee reauthorization bill.
Now that the House of Representatives and the Senate HELP Committee have passed their respective FDA user fee bills, House and Senate negotiators have been working to conference and reconcile differences in both bills.
While this week both the House and Senate are on recess, last week the Senate HELP Committee began the process of meeting to discuss and ultimately pass the Prescription Drug User Fee Act (PDUFA).
The Senate HELP Committee will vote next Wednesday, January, 12, on whether to send Dr. Robert Califf’s nomination as FDA commissioner to the Senate floor for a confirmation vote.
Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.
Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.
Here are the Federal Register notice summary excerpts that might be of interest to you or others within your organization. Please see notices for complete details.
