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User Fees

November 14, 2016 | Daily News

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.

November 08, 2016 | Daily News

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.

October 21, 2016 | Daily News

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).

September 30, 2016 | Daily News

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).

September 23, 2016 | Daily News

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.

September 16, 2016 | Daily News

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.

August 26, 2016 | Daily News

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.

August 22, 2016 | Daily News

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.

August 15, 2016 | Daily News

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.

August 04, 2016 | Daily News

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.

July 20, 2016 | Daily News

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.

July 15, 2016 | Daily News

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.

July 14, 2016 | Daily News

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.

June 20, 2016 | Daily News

The American Academy of Pediatricians (AAP) says its near decade-long press for FDA to establish safety and efficacy of over-the-counter cough and cold products for children shows a dire need to reform the OTC monograph process and increase agency resources through a user fee program.

June 20, 2016 | Daily News

FDA recently kicked off discussions on developing a user fee program for over-the-counter (OTC) drug products, expounding on the lack of resources the agency has to finish outstanding monographs with a staff of only 18 full-time employees regulating a market of more than 100,000 products.

June 03, 2016 | Daily News

FDA and the medical device industry continue to disagree on key issues as discussions continue on how to craft the next device user fee law, according to minutes of an April 27 meeting between the parties.

May 10, 2016 | Daily News

FDA will hold a public meeting on June 10 to explore setting up a user fee program to help fund reviews of over-the-counter (OTC) drug monographs, saying the agency's OTC program is severely under resourced and reviews could stall.

May 02, 2016 | Daily News

Key medical device lobby groups told FDA at a recent meeting that the agency's high-priority goals for the next user fee law don't match industry's, and said their members oppose the agency's real-world evidence funding plan and other proposals they believe are not worth the investment and don't fit into the scope of the user fee program, according to minutes from the March meeting.

March 31, 2016 | Daily News

FDA's drug regulatory policy chief Jane Axelrad will step down the end of April after serving at the agency for 25 years and playing an integral role in FDA reform and user fee negotiations.

January 28, 2016 | Daily News

FDA drug chief Janet Woodcock gave a small opening to the agency factoring drug price spikes in how it queues generic drug approvals, telling a Senate panel Thursday that such a policy might be possible if HHS came up with a “bullet proof” way of defining a price spike.