jueves, 20 de octubre de 2016

GDUFA Reauthorization Public Meeting / PAS Submissions / Substitutability of Generic Drugs Public Workshop

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

1. FDA to hold a public meeting on GDUFA Reauthorization
The FDA and representatives from the generic drug industry have reached an agreement in principle on proposed recommendations for the first reauthorization of the generic drug user fee program. The FDA published the draft agreement for public comment and will hold a public meeting on Oct. 21st, 2016 to hear additional public comments. The final recommendations are scheduled to be delivered to Congress in January 2017.
As part of the second iteration of the Generic Drug User Fee Amendments (GDUFA), the draft commitment letter incorporates several lessons learned over the last five years. Industry stakeholders support the provisions in the draft commitment letter.
Major changes included in the draft commitment letter and user fee structure:
- Review of performance goals will be streamlined and consolidated;
  • All ANDAs and ANDA amendments would fall within a single, consolidated review goals scheme to simplify and streamline program administration, promote review efficiency, and ensure that “no submission is left behind”
  • GDUFA II would create faster review goals for priority submissions. For an ANDA, standard review would be 10 months from submission and priority review would be 8 months from submission. 
- There will be a new pre-ANDA program, with product development, pre-submission and mid-review-cycle meetings;
- The user fee structure will be significantly restructured, helping to provide resources appropriate for our workload.
- The new user fee structure will address small businesses concerns;
  • A facility will not pay an annual facility fee unless it is identified in at least one approved generic drug submission 
  • Contract Manufacturing Organizations, generally small businesses that are hired by ANDA sponsors to manufacture their generic drugs, would pay only one-third the annual fee paid by firms that manufacture under ANDAs which they or their affiliates own 
  • A tiered generic drug applicant fee will feature a small tier (1-5 approved ANDAs); the fee will be one-tenth of a full program fee.
2. Abbreviated New Drug Application Submissions—Prior Approval Supplements Under GDUFA; Guidance for Industry
This guidance explains how GDUFA relates to PAS submissions. It also describes the performance metric goals outlined in the GDUFA Commitment Letter that FDA has agreed to meet, and clarifies how FDA will handle a PAS and amendments to a PAS for an ANDA subject to the GDUFA performance metric goals.
3. Substitutability of Generic Drugs: Perceptions and Reality; Public Workshop
FDA, in collaboration with the Johns Hopkins University Center of Excellence in Regulatory Science and Innovation, is announcing a public workshop entitled ‘‘Substitutability of Generic Drugs: Perceptions and Reality.’’ The objective of this workshop is to discuss FDA and industry practices related to postmarket surveillance of generic drugs, postmarket generic drug research activities, public perceptions of generic drug quality and effectiveness, and verification of therapeutic equivalence of generic drugs. This workshop will also give stakeholders, including scientists from government, academia, and industry, patient advocacy groups, clinicians, pharmacists, and the general public an opportunity to provide their insights on future research needs in postmarket surveillance of generic drugs.
The public workshop will be held on November 18th, 2016, from 8:30 a.m. to 4:30 p.m. at FDA’s White Oak Campus in Silver Spring, MD.