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User Fees

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.

July 16, 2018 | Daily News

The House passed via voice vote on Monday (July 16) legislation to reauthorize FDA's animal drug and animal generic drug user fee programs.

May 09, 2018 | Daily News

The House Energy & Commerce Committee on Wednesday (May 9) voted to send to the floor legislation that would reform FDA’s decades-old process for reviewing over-the-counter drugs, even as lawmakers continued to grapple with the 18-month period of exclusivity that the bill would grant to manufacturers of innovative OTC drugs.

May 08, 2018 | Daily News

The House Energy & Commerce Committee on Wednesday (May 9) will mark up legislation that would set up a user fee program for and reform FDA's decades-old process for reviewing over-the-counter drugs, the committee announced Monday evening (May 7).

April 27, 2018 | Daily News

A bipartisan group of House lawmakers hopes to add to the animal drug user fee package moving through Congress a measure that would expand the scope of FDA's animal drug conditional approval pathway so that it applies to large populations of animals.

April 24, 2018 | Daily News

The Senate health committee on Tuesday (April 24) voted 22-1 in favor of reforming FDA's nearly 50-year-old monograph process for reviewing over-the-counter (OTC) drugs via legislation that would authorize a new FDA user fee program for OTC drugs and provide two years of exclusivity for a drug developer that submits original human data on its drug.

March 14, 2018 | Daily News

Like their colleagues in the Senate did last month, members of the House Energy & Commerce health subcommittee considered Wednesday (March 14) draft language to reauthorize the Animal Drug User Fee Agreement (ADUFA) and the Animal Generic Drug User Fee Agreement (AGDUFA).