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User Fees

June 07, 2021 | Daily News

FDA and industry are in talks about how the agency can support scientific research around and issue guidance on biosimilar interchangeability, according to a summary of a recent biosimilars user fee meeting.

June 01, 2021 | Daily News

The White House Office of Management and Budget is reviewing a proposed rule on health insurance exchanges for 2022 and beyond that is expected to revise the Trump administration’s state innovation guidance, reverse the Trump-era proposal to let states leave healthcare.gov, increase the exchange user fees and more.

May 28, 2021 | Daily News

The Biden administration’s fiscal 2022 budget released Friday (May 28) proposes giving FDA $3.6 billion in budget authority, which FDA says would provide an 8% increase over fiscal 2021 enacted levels, though FDA watchers assert it would actually add up to an 11% increase.

April 21, 2021 | Daily News

Medical device manufacturers and FDA are at odds over how to use $200 million in revenue left over from the current round of medical device user fees.

March 25, 2021 | Daily News

FDA announced Thursday (March 25) that it has raised facility fees for its over-the-counter monograph user fee program to make up for the lack of revenue from non-traditional hand sanitizer manufacturers that temporarily entered the market provide sanitizer during the COVID-19 pandemic and were then carved out of the user fee program by the Trump administration.

January 06, 2021 | Daily News

HHS late Tuesday evening (Jan. 5) indicated it planned to exempt distilleries and other small businesses that supplied hand sanitizer during the COVID-19 public health emergency from FDA’s over-the-counter monograph user fee program.

July 31, 2020 | Daily News

FDA will increase its generic drug user fee application and drug master file fees in fiscal 2021 while reducing overall generic program and facility fees across the board, the agency announced Friday (July 31).

July 31, 2020 | Daily News

FDA plans to reduce fees for its biosimilar product development (BPD) program in fiscal 2021 and to keep overall biosimilar user fee program and application fees at their fiscal 2020 levels, the agency announced Thursday (July 30).

July 29, 2020 | Daily News

FDA announced Wednesday (July 29) that it will decrease application costs for its prescription drug user fee program in fiscal 2021, but it will increase overall program fees by about $11,000 over fiscal 2020 levels, for a total of about $336,000.

July 29, 2020 | Daily News

Patient and consumer organizations want FDA to use funding from prescription drug user fees to develop educational materials for patients that explain off-label drug use.

July 28, 2020 | Daily News

The brand drug lobby and patient groups say the next iteration of prescription drug user fee legislation should expand use of decentralized clinical trials and digital health technologies that can collect data remotely.

July 27, 2020 | Daily News

A generic drug lobby official urged FDA officials to allocate more generic drug user fees toward improving the rate of first-cycle generic drug application approvals. Increasing first-cycle approvals could help increase the safety and availability of generic product, which could also facilitate access to more affordable drugs, the lobbyist said.

May 27, 2020 | Daily News

FDA anticipates it may not be able to continue meeting its prescription drug and biosimilars user fee goal dates, as many of its staff members are focusing on COVID-19 activities, the agency says in guidance published Tuesday (May 26).

April 23, 2020 | Daily News

Even as FDA dedicates significant time and manpower to its COVID-19 response efforts, the agency continues to move forward on the new over-the-counter monograph regulatory and user fee framework, which was passed into law in late March.

February 10, 2020 | Daily News

The Trump administration wants to move the Center for Tobacco Products out of FDA and establish a new HHS agency to regulate tobacco -- a proposal opposed by major public health organizations and the head of the House Appropriations Committee.

February 06, 2020 | Daily News

The biosimilars industry and FDA will grapple with myriad regulatory shifts in 2020, with one of the most immediate challenges being the drug-to-biologic transition that some brand and generic drug makers will face next month.

January 22, 2020 | Daily News

Heading into 2020, third-party medical device servicers will focus on two key issues: extending right-to-repair laws to medical devices, and addressing cybersecurity on older medical devices, industry representatives told Inside Health Policy.

December 10, 2019 | Daily News

The Senate passed over-the-counter (OTC) drug monograph reform legislation by a vote of 91-2 on Tuesday (Dec. 10), coming after the lower chamber’s counterpart bill, reintroduced over the summer, was added to the House GOP’s drug pricing legislation.

December 10, 2019 | Daily News

The U.S. District Court of the District of Columbia ruled on Friday (Dec. 6) that FDA cannot regulate Genus Medical Technologies’ barium sulfate contrast agent as a drug because it qualifies as a medical device under the statute.

October 24, 2019 | Daily News

The Senate health committee will mark up over-the-counter drug monograph reform legislation along with seven other public health bills on Thursday (Oct. 31), according to an announcement from committee Chair Lamar Alexander (R-TN).