jueves, 19 de diciembre de 2013

CDER Small Business Update: New Notices and Guidance Documents

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
FDA/CDER's Small Business Assistance

New Notices and Guidance Documents
1. Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph  
FDA issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections. Under the proposal, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabeled to remain on the market.
This action is part of a larger, ongoing review of antibacterial active ingredients by the FDA to ensure these ingredients are proven to be safe and effective. This proposed rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings. 

Read more at:

Over-the-Counter Topical Antimicrobial Drug Products -- Antibacterial Hand Soaps and Body Washes

2. Pilot Program for Parallel Review of Medical Products; Extension of the Duration of the Program
FDA and the Centers for Medicare and Medicaid Services (CMS) (the Agencies) are announcing the extension of the ``Pilot Program for Parallel Review of Medical Products.'' The Agencies have decided to continue the program as currently designed for an additional period of 2 years from the date of publication of the Federal Register notice.
3. Draft Guidance for Industry: Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted under an ANDA
This guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements. The guidance describes how to meet the BE requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations. The guidance is generally applicable to dosage forms intended for oral administration and to non-orally administered drug products in which reliance on systemic exposure measures is suitable for documenting BE (e.g., transdermal delivery systems and certain rectal and nasal drug products). We believe that the guidance will also be useful when planning BE studies intended to be conducted during the post-approval period for certain changes in an ANDA.
4. FDA to Extend Comment Period on Proposed Rule on Safety Labeling Updates By Brand and Generic Drug Manufacturers (“Changes Being Effected” Supplements proposed rule)

FDA has decided to extend the comment period by 60 days for the proposed rule on “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products” (“Changes Being Effected” Supplements proposed rule). The comment period on the proposed rule will be extended to March 13, 2014, and the comment period on information collection issues under the Paperwork Reduction Act of 1995 will be extended to February 11, 2014. This extension is being provided in response to requests to provide interested persons with additional time to submit comments.

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