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User Fees

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).

February 28, 2018 | Daily News

The Senate health committee voted 22-1 Wednesday (Feb. 28) to advance reauthorization of the Animal Drug and Animal Generic Drug User Fee Amendments to the Senate floor.

September 14, 2017 | Daily News

Lawmakers may need to tweak provisions in the recently released over-the-counter monograph reform discussion draft that give FDA authority to issue administrative orders on packaging requirements for OTC drugs and to award two years of exclusivity to OTC drug manufacturers. FDA and stakeholders pointed to both provisions as issues that require a second look from Congress during the House Energy & Commerce health subcommittee’s Wednesday (Sept. 13) hearing on the bill.

September 14, 2017 | Daily News

House Energy & Commerce Committee Democrats Frank Pallone (NJ), Debbie Dingell (MI) and Jan Schakowsky (IL) said they hope the committee will consider setting up an FDA user fee program for cosmetics, noting that reforming the agency's oversight of cosmetics is on their priority lists.

September 11, 2017 | Daily News

House lawmakers released Monday (Sept. 11) a bipartisan discussion draft of their proposed over-the-counter monograph user fee program (OMUFA), coming two days ahead of an Energy & Commerce health subcommittee hearing on ways to reform the OTC monograph process.

September 05, 2017 | Daily News

The House Energy & Commerce Committee will hold a hearing on over-the-counter (OTC) monograph user fees Sept. 13, a congressional aide tells Inside Health Policy.

August 18, 2017 | Daily News

President Donald Trump signed Friday (Aug. 18) the FDA Reauthorization Act of 2017, a White House spokesperson tells Inside Health Policy.

August 10, 2017 | Daily News

An over-the-counter (OTC) industry source expressed concern over calls that OTC monograph reform legislation include cosmetics regulations, saying that could slow things down and detract from the goal of getting the legislation passed as soon as possible.

August 08, 2017 | Daily News

FDA will hold a public meeting Sept. 18 to examine the experiences of the agency and stakeholders with structured benefit-risk assessments and approaches to incorporating patient perspectives in these assessments, according to a Tuesday (Aug. 8) agency notice.

August 04, 2017 | Daily News

A Democratic senator is redoubling calls for Congress to pass her bill granting FDA recall authority over cosmetics.

August 03, 2017 | Daily News

Public Citizen is claiming victory after Sens. Orrin Hatch (R-UT) and Bob Menendez (D-NJ)'s Orphan Product Extensions Now Accelerating Cures and Treatments (OPEN) Act, which would extend exclusivity for orphan drugs by six months, was not brought up as part of the FDA user fee package passed by the Senate Thursday (Aug. 3).

August 03, 2017 | Daily News

The Senate passed 94-1 Thursday (Aug. 3) the FDA Reauthorization Act, sending the user fee legislation to the president’s desk.

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