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User Fees

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).

September 19, 2019 | Daily News

House Speaker Nancy Pelosi (D-CA) on Thursday (Sept. 19) unveiled her long-awaited government price negotiation plan, which would give HHS the power to negotiate drug prices that would apply to all payers.

July 24, 2019 | Daily News

Acting FDA Commissioner Ned Sharpless told agency staff in an email Tuesday (July 23) that his top priorities are to develop frameworks for regulating new technologies; invest in the agency’s workforce; help to lower drug prices by encouraging drug competition; and improve postmarket surveillance of regulated products.

February 28, 2019 | Daily News

The medical device lobby applauded a bill that would let FDA collect new user fees during a lapse in agency funding, allowing the agency to continue reviewing device applications in the event of a future government shutdown.

September 17, 2018 | Daily News

Seven major health organizations, including the Consumer Healthcare Products Association, Pew Charitable Trusts and American Academy of Pediatrics, are urging Congress to swiftly pass legislation that would reform the system under which over-the-counter (OTC) drugs are regulated and brought to market.

July 31, 2018 | Daily News

The Senate on Tuesday (July 31) passed by voice vote the Animal Drug User Fee and Animal Generic Drug User Fee Amendments (ADUFA/AGDUFA), which reauthorize FDA’s animal drug and generic drug user fee programs.

July 16, 2018 | Daily News

The House on Monday (July 16) passed an over-the-counter (OTC) monograph reform bill by voice vote that would amend FDA's OTC drug review process, set in place a user fee system known as OMUFA and grant 18 months of exclusivity to makers of innovative OTC drugs.