Pharmaceutical Policy

Documents

FDAOpen for comment

Citizen Petition from The Doctor Patient Forum

1,494 comments

Net support +41% across analyzed comments

Top issues in comments

  • Patient access to pain medication
  • Narxcare regulation
  • Patient stigmatization and discrimination
Read the record →
FDAOpen for comment

Citizen Petition from Alliance to Protect Insulin Choice

41 comments

Net support +78% across analyzed comments

Top issues in comments

  • Insulin availability and alternatives
  • Basal insulin action profile
  • Insulin use in pregnancy
Read the record →
FDAOpen for comment

Citizen Petition from Pharmaceutical Safety Oversight Council

6 comments

Net support +100% across analyzed comments

Top issues in comments

  • Adverse drug reactions
Read the record →
FDAOpen for comment

Citizen Petition from Alliance for Pharmacy Compounding

3 comments

Net support +33% across analyzed comments

Top issues in comments

  • Regulatory classification of dte
  • Safety and efficacy of dte
Read the record →
FDAOpen for comment

Citizen Petition from Evan H. Couture

2 comments

Net support +100% across analyzed comments

Top issues in comments

  • Regulatory consistency
  • Regulatory parity and consistency
Read the record →
CMSOpen for comment

Medicare Program: Medicare Drug Price Negotiation Program and Medicare Prescription Drug Benefit Program

0 comments

Analysis in progress

Top issues in comments

Not yet determined
Read the record →Closes Aug 18
FDAOpen for comment

Vanda Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon)

0 comments

Analysis in progress

Top issues in comments

Not yet determined
Read the record →Closes Jul 7
FDAOpen for comment

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice (CGMP): Manufacturing, Processing, Packing, and Holding of Drugs; GMP for Finished Pharmaceuticals (Including Active Pharmaceutical Ingredients) and the Advanced Manufacturing Technologies Designation Program

0 comments

Analysis in progress

Top issues in comments

Not yet determined
Read the record →Closes Jun 23
FDAOpen for comment

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience/Events With Approved New Animal Drugs

0 comments

Analysis in progress

Top issues in comments

Not yet determined
Read the record →Closes Jun 23
FDAOpen for comment

Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments; Public Meeting; Request for Comments

0 comments

Analysis in progress

Top issues in comments

Not yet determined
Read the record →Closes Jul 24
FDAOpen for comment

Suitability Petition from Felix Pharmaceuticals Pvt. Ltd.

0 comments

Analysis in progress

Top issues in comments

Not yet determined
Read the record →
FDAOpen for comment

Suitability Petition from Hyman, Phelps, & McNamara P.C.

0 comments

Analysis in progress

Top issues in comments

Not yet determined
Read the record →Closes Nov 25