Which federal agency does Association for Accessible Medicines comment on most?

Association for Accessible Medicines is most active at the Food and Drug Administration.

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Association for Accessible Medicines

Unclaimed

Industry

Pharmaceuticals

Staff

601 New Jersey Ave NW, Washington, DC

Phone

+1 202-249-7100

Website

accessiblemeds.org

Engagement overview

Association for Accessible Medicines has filed 230 public comments across 196 dockets at 9 federal agencies, most actively at the Food and Drug Administration.

Association for Accessible Medicines

Engagement overview

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Agency footprint

Dockets · FDA (159)

Drug Repurposing for Unmet Medical Needs; Request for Information

Commissioner’s National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments

New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers; Draft Guidance for Industry; Availability

Establishing Impurity Specifications for Antibiotics; Draft Guidance for Industry; Availability

Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments.

Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009

Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry; Availability

Q3E Guideline for Extractables and Leachables; International Council for Harmonisation; Draft Guidance for Industry; Availability

Increasing Availability of Nonprescription Drugs; Request for Information

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

Biosimilar User Fee Act

Onshoring Manufacturing of Drugs and Biological Products; Public Meeting; Request for Comments

Advancing the Development of Interchangeable Products: Identifying Future Needs; Public Workshop; Request for Comments

Biosimilar User Fee Act III Regulatory Science Program Interim Public Meeting; Public Meeting; Request for Comments

Unique Device Identifier (UDI) Requirements for Combination Products; Draft Guidance for Industry and FDA Staff; Availability

Q1 Stability Testing of Drug Substances and Drug Products; International Council for Harmonisation; Draft Guidance for Industry; Availability

Reauthorization of the Generic Drug User Fee Amendments; Public Meeting; Request for Comments

M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms; International Council for Harmonisation; Draft Guidance for Industry; Availability

Replacing Color Additives in Approved and Marketed Drug Products; Draft Guidance for Industry; Availability

Control of Nitrosamine Impurities in Human Drugs; Guidance for Industry; Availability

Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability

Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway; Draft Guidance for Industry; Availability

Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry; Availability

E6(R3) Good Clinical Practice: Annex 2; International Council for Harmonisation; Draft Guidance for Industry; Availability

Best Practices for FDA Communication with Interested Parties

Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics; Draft Guidance for Industry; Availability

Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Elements and Terminologies; Establishment of a Public Docket; Request for Comments

Agency Information Collection Activities; Proposed Collection; Comment Request; Promotion of Prescription Drugs Within a Talk Show Format

Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products; Draft Guidance for Industry; Availability

Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers; Draft Guidance for Industry; Availability

Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices

M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies that Utilize Real-World Data for Safety Assessment of Medicines; International Council for Harmonisation; Draft Guidance for Industry; Availability

Platform Technology Designation Program; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

Considerations in Demonstrating Interchangeability With a Reference Product

Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs; Draft Guidance for Industry; Availability

Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act

Data Integrity for In Vivo Bioavailability and Bioequivalence Studies; Draft Guidance for Industry; Availability

Handling and Retention of Bioavailability and Bioequivalence

Conducting Remote Regulatory Assessments—Questions and Answers; Draft Guidance for Industry; Availability

Medication Guides: Patient Medication Information; Proposed Rule

Food and Drug Administration’s Draft Report and Plan on Best Practices for Guidance; Availability

Quality Considerations for Topical Ophthalmic Drug Products; Draft Guidance for Industry; Availability

Implementing Interoperable Systems and Processes for Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket; Request for Information and Comments

Translation of GLP Study Reports: Questions and Answers; Draft Guidance for Industry; Availability

Advanced Manufacturing Technologies Designation Program; Draft Guidance for Industry; Availability

Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities; Draft Guidance for Industry; Availability

Quality Management Maturity Program for Drug Manufacturing Establishments; Establishment of a Public Docket; Request for Comments

Post-Warning Letter Meetings Under the Generic Drug User Fee Act (GDUFA); Draft Guidance for Industry; Availability

Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act – Compliance Policies; Guidance for Industry; Availability

Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products; Draft Guidance for Industry

Classification Categories for Certain Supplements Under BsUFA III; Draft Guidance for Industry; Availability

E6(R3) Guideline for Good Clinical Practice; International Council for Harmonisation; Draft Guidance for Industry; Availability

Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products; Availability

Proposed Changes to Third-party Vendors; Establishment of a Public Docket; Request for Comments

Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities in Human Drug Products; Establishment of a Public Docket; Request for Comments

Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request”

Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; request for information and comments.

Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA; Draft Guidance for Industry; Availability

BsUFA III Regulatory Research Pilot Program Request for Comment on Research Roadmap

ANDAs: Pre-Submission Facility Correspondence Associated with Priority Submissions

Controlled Correspondence Related to Generic Drug Development

Statistical Approaches Establishing Bioequivalence

DSCSA Implementation and Readiness Efforts for 2023; Public Meeting; Request for Comments

Sameness Evaluations in an Abbreviated New Drug Application – Active Ingredients; Draft Guidance for Industry; Availability

Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA; Draft Guidance for Industry; Availability

Nonprescription Drug Product With an Additional Condition for Nonprescription Use; Proposed Rule

Revising the National Drug Code Format and Drug Label Barcode Requirements

Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

Soliciting Public Comment on Appendix A of FDAs July 2018 Guidance Entitled ANDA Submissions Amendments to Abbreviated New Drug Applications Under GDUFA; Notice; Establishment of a Public Docket; Request for Comments

Evaluation of Therapeutic Equivalence; Draft Guidance for Industry; Availability

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information; Availability

Identifying Trading Partners Under the Drug Supply Chain Security Act

National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers

Risk Management Plans to Mitigate the Potential for Drug Shortages; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request