viernes, 31 de octubre de 2014

CDER SBIA Update: Guidances, Meetings, and Programs

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

Guidances, Meetings, and Programs
1. Drug Quality Sampling and Testing Programs
Every year, FDA monitors and tests hundreds of drug products and active pharmaceutical ingredients to help ensure safe, effective and high-quality products are available to consumers.
FDA has posted details of our postmarket drug quality sampling and testing programs to provide product safety and effectiveness test results to health care professionals and consumers. 
Please visit our Drug Quality Sampling and Testing page to learn more about FDA’s efforts to help ensure the regulatory standards for brand name and generic drugs continue to be met throughout a product’s lifecycle.

2. Investigational New Drug Sponsors During Drug Development; Request for Comments

FDA is announcing the establishment of a docket to receive suggestions, recommendations, and comments from interested parties, including academic institutions, regulated industry, and other interested organizations on best practices for communication between FDA and investigational new drug application (IND) sponsors during drug development. These comments will help FDA identify and ultimately establish best practices to be included in a draft guidance for industry and review staff.
3. Circumstances That Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection; Guidance for Industry
The Food and Drug Administration Safety and Innovation Act (FDASIA) added a provision to the Food, Drug, and Cosmetic Act (the FD&C Act) concerning inspections that makes a drug adulterated. This guidance defines the types of actions, inaction, and circumstances that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated.
4. Migraine: Developing Drugs for Acute Treatment; Draft Guidance for Industry  
The purpose of this guidance is to assist sponsors in the clinical development of drugs for the acute treatment of migraine. This guidance focuses on specific drug development and trial design issues that are unique to the study of drugs for the acute treatment of migraine. This guidance is intended to serve as a focus for continued discussions among the Division of Neurology Products, pharmaceutical sponsors, the academic community, and the public.
5. Clinical Investigator Training Course: November 4-6, 2014, The Holiday Inn Washington, 10000 Baltimore Avenue, College Park, MD.
This extensive 3-day course focuses on nonclinical, early clinical, and phase 3 studies; issues in the design and analysis of trials; safety and ethical considerations; and FDA's regulatory requirements related to the performance and evaluation of clinical studies. Attendees will have the unique opportunity of hearing directly from FDA’s nationally renowned experts on issues critical to successful clinical research. The course is designed for physicians, nurses, pharmacists, and other health care professionals involved in clinical trials.
For more information on the course and how to register, see: FDA’s Clinical Investigator Training Course .

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.
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