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User Fees

Thursday, 09 February 2017

HHS personnel slots listed as exempt from President Donald Trump's federal hiring freeze appear to apply to some FDA drug center generic drug user fee hires, according to an internal HHS memo and an FDA drug center list of job opportunities.

Tuesday, 07 February 2017

The White House Office of Management and Budget received a request detailing which jobs HSS wants exempted from President Donald Trump's federal hiring freeze, an OMB spokesperson told Inside Health Policy Tuesday (Feb. 7), but details on which, if any, FDA jobs were requested for exemption remain unclear.

Monday, 30 January 2017

House Energy & Commerce Democrats on Monday (Jan. 30) asked President Donald Trump to provide details on whether FDA user fee programs will be exempted from the federal hiring the White House announced Jan. 23.

Wednesday, 25 January 2017

Public health jobs, such as those at FDA, could certainly fall under the public safety exemption in President Donald Trump's presidential memorandum hiring freeze, a White House spokesperson told Inside Health Policy Wednesday (Jan. 25).

Monday, 23 January 2017

President Donald Trump signed a presidential memorandum freezing federal government hiring Monday (Jan. 23), potentially damaging FDA's efforts to fill 1,000 vacancies at the agency if FDA jobs are not exempted under the memo's clause exempting personnel needed for public safety or those deemed by the Office of Personnel Management chief as “otherwise necessary.”

Thursday, 29 December 2016

FDA’s efforts to fill 1,000 vacancies at the agency, boosted by provisions in the 21st Century Cures Act, could be jeopardized by President-elect Donald Trump’s proposed federal government hiring freeze, warned Steven Grossman, deputy executive director of the Alliance for a Stronger FDA.

Tuesday, 20 December 2016

Over a dozen Senate Democrats urged President-elect Donald Trump to tackle high prescription drug costs and suggested in a letter Tuesday (Dec. 20) that upcoming FDA user fee bills offer an “ample opportunity” for him to do so.

Monday, 14 November 2016

Conducting research on how to establish equivalence of complex drug products is among the five fiscal 2017 scientific priorities of FDA's generic drug office.

Tuesday, 08 November 2016

The National Center for Health Research is criticizing FDA for having fewer meetings with patients and public health advocates during the biosimilar user fee negotiations than during other use fee negotiations, and said this lack of engagement makes it difficult for the group to judge whether the new user fee agreement is adequate.

Friday, 21 October 2016

The next round of the generic drug user fee program will tie industry fees to approved abbreviated new drug applications as opposed to requiring industry to pay fees when an application is submitted regardless of whether it is approved, FDA said Friday (Oct. 21).

Friday, 30 September 2016

The controversial pediatric review voucher program will survive another three months following President Barack Obama's signature of a short-term stopgap bill Friday (Sept. 30).

Friday, 23 September 2016

FDA reached a draft user fee pact with the generic drug industry that calls for a new approval pathway for drugs with complex active ingredients and formulations, as well as for drug-device combinations.

Friday, 16 September 2016

FDA unveiled goals for the second iteration of the biosimilar user fee program Friday (Sept. 16) that include a call for more communication between applicants and the FDA review team to minimize the number of review cycles needed for approval.

Friday, 26 August 2016

FDA and the medical device industry have agreed that if Congress enacts legislation in fiscal year 2017 allowing the device center to increase pay for scientists and other professional positions, as proposed in the House-passed 21st Century Cures bill, they will craft a plan aimed at retaining key personnel currently funded in part by user fees, according to minutes of recent meetings.

Monday, 22 August 2016

FDA and the medical device industry appear to have smoothed out a point of contention in negotiations for the user fee reauthorization by including plans for a pilot to assess the effectiveness of real-world evidence to support premarket activities, according to statements by the agency and the industry groups outlining a tentative agreement on user fee goals.

Monday, 15 August 2016

FDA officials, patient representatives and industry stakeholders said the hiring provisions included in the drug user fee commitment letter are critical to the other goals outlined for the sixth iteration of the program, with an industry representative saying FDA’s ability to recruit scientists is crucial to the agency keeping pace with scientific advancement.

Thursday, 04 August 2016

The National Organization for Rare Disorders (NORD) commended the sixth drug user fee agreement, released July 15, for its potential benefits to the rare disease community, but a NORD official told Inside Health Policy that the group will work with lawmakers to offer amendments to the bill.

Wednesday, 20 July 2016

A head biotechnology industry lobbyist says FDA hopes to send the final prescription drug user fee goals letter to Congress before the end of the year to avoid the “hiatus pit” that occurs during the changes of administration.

Friday, 15 July 2016

FDA and the drug industry have agreed on performance goals for the sixth iteration of the drug user fee law that echo key objectives of the House-passed 21st Century Cures Act, including: enhancing adaptive, Bayesian and other clinical trial designs, incorporating the patient voice in drug development and enhancing the review of combination products.

Thursday, 14 July 2016

FDA device chief Jeffrey Shuren made a public case for a national device evaluation system in a July 11 article in a prominent medical journal that says adding unique device identifiers to claims forms and securing industry funding are key to the effort.

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