jueves, 1 de octubre de 2015

CDER SBIA Update: Recent FDA Notices and Guidances

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)
Recent FDA Notices and Guidances
1. Fee for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2016
FDA is announcing the fee rate for using a rare pediatric disease priority review voucher for fiscal year (FY) 2016. Rare pediatric disease priority review vouchers are awarded to the sponsors of certain rare pediatric disease product applications, submitted 90 days or more after July 9, 2012, upon FDA approval of such applications. This notice establishes the rare pediatric disease priority review fee rate for FY 2016 and outlines the payment procedures for such fees.
2. Homeopathic Product Regulation: Evaluating the Food and Drug Administration's Regulatory Framework After a Quarter-Century; Reopening of the Comment Period
FDA is reopening the comment period for the notice of public hearing that appeared in the Federal Register of March 27, 2015. In the notice of public hearing, FDA requested comments on a number of specific questions identified in the document. The Agency is taking this action in response to requests to allow interested persons additional time to submit comments.
3. Biosimilar User Fee Act; Stakeholder Meetings on Biosimilar User Fee Act of 2012 Reauthorization; Request for Notification of Regulated Industry Organization Intention To Participate
FDA is issuing this notice to request that industry trade associations, whose members include drug companies currently engaged in development or manufacture of biosimilar biological products in the U.S., or drug companies intending to engage in these activities during the period of FY 2018-2022, notify FDA of their intent to participate in industry stakeholder meetings in support of timely reauthorization of the Biosimilar User Fee Act of 2012 (BsUFA). The statutory authority for BsUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue collecting user fees to fund the biosimilar biological product review process.
4. Biosimilar User Fee Act; Public Meeting
FDA is announcing a public meeting on the reauthorization of the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2018 through 2022. BsUFA authorizes FDA to collect user fees for the process for the review of biosimilar biological products. The current legislative authority for BsUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA begin the BsUFA reauthorization process by publishing a notice in the Federal Registerrequesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment on the BsUFA performance goals as the Agency begins the process to reauthorize the program in FYs 2018-2022.
The public meeting will be held on December 18, 2015, from 9 a.m. to 2 p.m at the FDA White Oak Campus in Silver Spring, MD. Registration to attend the meeting must be received by November 18, 2015.
5. E6(R2) Good Clinical Practice; International Conference on Harmonisation; Draft Guidance for Industry
FDA is announcing the availability of a draft guidance entitled “E6(R2) Good Clinical Practice.” The draft guidance amends the guidance entitled “E6 Good Clinical Practice: Consolidated Guidance” (E6(R1)) to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also updates standards regarding electronic records and essential documents. The draft guidance is intended to improve clinical trial quality and efficiency while maintaining human subject protection. FDA is making this draft guidance available for comment on the sections that are additions to ICH E6(R1) and marked as “ADDENDUM.”




The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.




Please take our CDER SBIA survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation

No hay comentarios: