Tag Archives: user fees

FDA Public Hearing on the Implementation of Generic Drug User Fee Amendments (Sept. 17)

This post was written by Jennifer Pike and Vicki Morris. On September 17, 2014 the Food and Drug Administration (“FDA”) is holding a public hearing at the College Park Marriot Hotel and Conference Center, in Hyattsville, MD, to discuss the Agency’s implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) and its obligations under … Continue Reading

Congressional Health Policy Hearings & Markups

On May 8, 2013, the House Energy and Commerce Subcommittee on Health approved by voice vote H.R. 1407, legislation to reauthorize and combine the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act. TheEnergy and Commerce Committee also recently held hearings on: the Administration’s HHS budget proposal; the Center for Consumer Information … Continue Reading

April Congressional Health Policy Hearings & Markups

Earlier this month, the Senate Finance Committee held a hearing on the nomination of Marilyn Tavenner to be CMS Administrator. The Senate Health, Education, Labor, and Pensions (HELP) Committee approved the Mental Health Awareness and Improvement Act, legislation that reauthorizes and amends programs administered by both HHS and the Department of Education related to awareness, prevention, … Continue Reading

President Signs Government Funding Bill Maintaining FY 2013 Medicare Sequestration Cuts

On March 26, 2013, President Obama signed into law H.R. 933, a continuing resolution  that averts a government shutdown by funding the government through the remainder of fiscal year 2013 (through September 30, 2013). The funding bill is subject to the sequestration order triggered by the Budget Control Act, although funding was increased for a limited … Continue Reading

Senate HELP Committee Approves Organ Transplant, Animal Drug User Fee Bills

On March 20, 2013, the Senate Committee on Health, Education, Labor, and Pensions approved an amended version of S. 330, a bill to amend the Public Health Service Act to establish safeguards and standards of quality for research and transplantation of organs infected with human immunodeficiency virus (HIV). Among other things, the bill would remove … Continue Reading

FDA Announces 2013 Generic Drug Active Pharmaceutical Ingredient and Finished Dosage Form Facility User Fee Rates

This post was written by Jennifer Pike. The FDA has announced the generic drug active pharmaceutical ingredient (API) and finished dosage form (FDF) facility user fee rates for fiscal year 2013. The API facility fee is owed by each person that owns a facility which produces, or which is pending review to produce, one or … Continue Reading

FDA Issues Generic Drug User/Backlog Fee Notices

This post was written by Jennifer Pike. On October 25, 2012, the Food and Drug Administration (FDA) published in the Federal Register the fiscal year (FY) 2013 rates for certain filings under the Generic Drug User Fee Program. Specifically, the notice establishes the new annual rates for an abbreviated new drug application (ANDA) ($51,520), prior … Continue Reading

Draft Guidance Regarding Self-Identification of Generic Drug Facilities and Q&A on Generic Drug User Fee Amendments

This post was written by Erin Janssen. On August 27, 2012, FDA issued draft guidance documents for industry entitled "Self-Identification of Generic Drug Facilities, Sites, and Organizations" and "Generic Drug User Fee Amendments of 2012: Questions and Answers." The Generic Drug User Fee Amendments of 2012 (GDUFA) requires that generic drug facilities, sites, and organizations around the … Continue Reading

FDA Establishes FY 2013 User Fee Rates for Biosimilars and Prescription Drugs

This post was written by Erin Janssen. The Food and Drug Administration (FDA) has announced the rates for biosimilar and prescription drug user fees for FY 2013. By way of background, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) authorizes FDA to assess and collect user fees for certain activities in connection with … Continue Reading

FDA Guidance on FY 2013 Medical Device User Fee Small Business Qualification and Certification

This post was written by Erin Janssen. The FDA has issued guidance on FY 2013 medical device user fees for small businesses. The guidance explains how a business may qualify as a “small business” and pay most FY 2013 medical device user fees at substantially discounted rates. While the guidance is substantively the same as the … Continue Reading

April Congressional Health Policy Hearings and Markups

The House Energy and Commerce Committee Health Subcommittee recently held a hearing on “FDA User Fees 2012: How Innovation Helps Patients and Jobs,” focusing on reauthorization of the Prescription Drug User Fee Act and the Medical Device User Fee Act.  In addition, the Senate Aging Committee examined the “Future of Long-Term Care: Saving Money by … Continue Reading

Congressional Hearings on Drug Issues.

Recent health policy hearings include a House Judiciary Committee Crime Subcommittee hearing on “The Prescription Drug Epidemic in America” and a House Energy and Commerce Health Subcommittee hearing on “FDA User Fees 2012: Issues Related to Accelerated Approval, Medical Gas, Antibiotic Development and Downstream Pharmaceutical Supply Chain.”… Continue Reading

FDA and Industry Reach Agreement in Principle on Medical Device User Fees

This post was written by Erin A. Janssen and Kevin M. Madagan. The FDA and representatives from the medical device industry reportedly reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program, according to an announcement released February 1, 2012 on the FDA’s website. FDA claims … Continue Reading

February Congressional Health Policy Hearings

The House Energy and Commerce Health Subcommittee has held hearings on reauthorization of the Prescription Drug User Fee Act and generic and biosimilar user fees, and an additional hearing on reauthorization of Medical Device User Fee Act is scheduled for February 15, 2012.  The House Ways and Means Health Subcommittee held a hearing on how … Continue Reading
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