CDER SBIA Update: Recent Guidance Documents and Notices

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry

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


Recent Guidance Documents and Notices

 

1. Draft Guidance for Industry on Current Good Manufacturing Practice-Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act  

This draft guidance describes FDA's current expectations regarding compliance with current good manufacturing practice (CGMP) requirements for facilities that compound human drugs and register with FDA as outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in accordance with provisions added by the Drug Quality and Security Act (DQSA). FDA is also soliciting public input on specific potential alternative approaches regarding certain CGMP requirements. These potential approaches are explained in detail in the draft guidance.

Guidance Document

Federal Register

 

2. Final Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act  

This guidance announces the Agency's intention with regard to enforcement of the FD&C Act to regulate entities that compound drugs, now that the FD&C Act has been amended by the DQSA. The guidance reflects the Agency's current thinking on the issues addressed by the guidance.

Guidance Document

Federal Register

 
3. Over-the-Counter Drug Monograph System-Past, Present, and Future; Public Hearing; Reopening of the Comment Period

FDA is reopening the comment period for the notice of public hearing, published in the Federal Register of February 24, 2014 (79 FR 10168), requesting comment on how to improve or alter the current Over-the-Counter (OTC) Monograph Process for reviewing nonprescription drugs marketed under the OTC Drug Review. FDA is reopening the comment period to update comments and to receive any new information.

Federal Register Notice

 

4. Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention  

The purpose of the guidance is to assist sponsors in the development of drugs for the treatment or prevention of neglected tropical diseases (NTDs). This guidance represents the FDA's current thinking regarding drug development for the treatment or prevention of NTDs, including clinical trial designs and internal review standards to support approval of drugs. This guidance finalizes the draft guidance issued August 24, 2011.

Guidance Document

Federal Register Notice

 

5. For Industry: Using Social Media

The Internet and various social media platforms have increasingly enabled drug and device manufacturers to more actively engage with consumers and healthcare professionals.

In November 2009, FDA held a Part 15 public hearing to gather comments and questions from our stakeholders (e.g., industry, health care professionals, consumers, patient groups, Internet vendors, advertising agencies, and other interested parties) on how FDA can best provide guidance on the promotion of FDA-regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools.

The public hearing was instrumental in providing an opportunity for our stakeholders to comment. In addition to the 77 live presentations, we received 72 comments to the docket—a major collaborative effort by both the Agency and our stakeholders.

The Office of Prescription Drug Promotion (OPDP) carefully considered input received both from outside and within the Agency and has since released four draft guidances that address various topics related to the public hearing. We look forward to receiving stakeholder feedback in the near future on the two draft guidances that were released on June 17, 2014, and to continuing our work in this ever-evolving landscape. The guidance documents and Federal Register Notices are located at For Industry: Using Social Media.


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 Small Business survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation


This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 Powered by GovDelivery