FDA’s CDER and CDRH Release 2015 Guidance Agenda and Comprehensive Document Search Tool

The Food and Drug Administration seems poised for a busy 2015. The Agency’s Center for Drug Evaluation and Research (CDER) just released their annual guidance document agenda for 2015. They intend to publish 90 guidance documents this year, including several aimed at advertising, biosimilars, pharmaceutical quality and manufacturing standards, and the Drug Supply Chain Security Act. The Center for Devices and Radiological Health (CDRH) released their 2015 plan as well–indicating Laboratory Developed Test and software-related guidances are in the works. To cap off a busy new year, FDA also released a well-organized guidance database and easy-to-use search tool which offers a marked improvement over the previous system.

Pharmaceutical Guidance

Advertising

FDA looks like it will tackle some important issues in upcoming guidance related to advertising, including how companies may promote products using health care economics (a long sought after guidance), social media promotion that includes links to third party sites, direct to consumer TV ads, and more guidance related to unapproved uses of approved medical products.

• Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs
• Direct-to-Consumer Television Advertisements –DTC Television Ad Pre-Dissemination Review Program for Human Drugs
• Health Care Economic Information in Promotional Labeling and Advertising for Prescription Drugs Under Section 114 of the Food and Drug Administration Modernization Act
• Internet/Social Media Advertising and Promotional Labeling of Prescription Drugs and Medical Devices – Use of Links to Third-Party Sites
• Manufacturer Communications Regarding Unapproved Uses of Approved Medical Products
• Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs

Biosimilars

2015 promises to be a big year for biosimilars, as three have now started the abbreviated pathway for FDA licensure established as part of the Biologics Price Competition and Innovation Act of 2009. Read our latest update on biosimilars here, which examines Novartis’s version of Neupogen, likely to become the first approved biosimilar in the US. FDA is looking to supplement last year’s guidance with four more this year, one of which addresses labeling, a contentious issue so far. 

• Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
• Considerations in Demonstrating Interchangeability to a Reference Product
• Labeling for Biosimilar Biological Products
• Statistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

Drug Supply Chain and Security Act

FDA has also planned to issue or finalize six guidance documents on track and trace as part of the Drug Supply Chain Security Act (DSCSA). We wrote an extensive article about requirements under the DSCSA earlier this week.

• DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third Party Logistics Providers
• DSCSA Implementation: Products Eligible for Grandfather Status
• DSCSA Implementation: Standards for the Interoperable Exchange of Information for Tracing Certain Human, Finished Prescription Drugs – Standardization of Data and Documentation Practices
• DSCSA Implementation: The Product Identifier for Human, Finished, Prescription Drugs
• DSCSA: Verification Systems for Prescription Drugs
• DSCSA Implementation: Waivers, Exceptions and Exemptions from Product Tracing Requirements

FDA also forecasts a very busy year regarding guidance on pharmaceutical quality. The intend to release 13 documents related to Chemistry, Manufacturing, and Controls (CMC) and 3 more on the subject of Current Good Manufacturing Practices. 

Other notable subjects include guidance on labeling, electronic submissions, and generics. View the entire list of 90 guidances here. 

Medical Device Guidance

The CDRH is a bit more conservative in their goals for 2015–the agency separates its workload into A-list and B-list based on priority. Looking down the list, FDA is focusing on Laboratory Developed Test (LDT) guidance, expedited access for devices meeting unment needs, premarket exemption guidance for low-risk devices, and medical device decision support software. FDA’s “A-List” includes the following:

Final Guidance Topics

• Applying Human Factors & Usability Engineering to Optimize Medical Device Design
• 510(k) Submissions for Medical Devices that Include Antimicrobial Agents  
• Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval
• Expedited Access for Premarket Approval of Medical Devices Intended for Unmet Need for Life Threatening of Irreversibly Debilitating Diseases or Conditions
• Framework for Regulatory Oversight of Laboratory Developed Tests
• FDA Notification and Medical Device Reporting for Laboratory Developed Tests
• Coronary Drug Eluting Stents-Nonclinical and Clinical Studies
• Intent to Exempt Certain Class II and Class I Reserved Medical Devices From Premarket Notification Requirements
• Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
• Safety Considerations for 510(k) Submissions to Mitigate the Risks of Misconnections With Small-bore Connectors Intended for Enteral Applications
• Submission and Review of Sterility Information in 510(k) Submissions for Devices Labeled as Sterile
• Use of ISO 10993-1, Biological Evaluation of Medical Devices Part I: Evaluation and Testing (Biocompatibility)

Draft Guidance Topics

• General Wellness Products
• Medical Device Accessories
• Medical Device Decision Support Software
• Benefit-Risk Factors to Consider When Reviewing IDE Submissions
• UDI Direct Marking
• Informed Consent: Policy for Observational Data Used to Fulfill Device Requirements
• Adaptive Design for Medical Device Clinical Studies
• UDI FAQs

For the full list of planned guidances click here. FDA also invites comments and suggestions for new or different guidance documents, including potential guidance topics, reasons the guidance is needed, and proposed policy for FDA to consider on the topic), relative priority of guidance documents, and/or suggestions that CDRH revise or withdraw a final guidance document. Submit electronic comments tohttp://www.regulations.gov and identify comments with docket number FDA-2012-N-1021. 

FDA’s new search tool

In addition to the list of guidances, 2015 has seen the FDA update its website to include a useful search tool option. Below we searched for FDA’s reprint guidance, which found the proper document. Some hitches still need to be worked out–the two July social media guidances are still not coming up in searches. Furthermore, the search term must be included exactly as it is seen in the guidance title. For example, “reprint” works, but “reprints” would not. Other searches–by product, date, subject–can also narrow results. Even if the tool is not yet perfect, it is definitely an improvement over the haphazard searching around FDA.gov that was often required to find a document.