1. A “Successful” FDA Submission: Key Components Needed
Nancy Taylor, Shareholder, Greenberg Traurig LLP
March 3, 2016

2. TOPICS FDA – What are the Regulatory Requirements?
Drugs? Devices? Foods? Cosmetics? Dietary Supplements?
Lessons Learned

3. FDA Requirements for Drugs/Biologics
Drug: generally, a SUBSTANCE intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
Biologic: Wide range of products (vaccines, blood and blood products, allergenics, somatic cells, gene therapy, tissues and recombinant therapeutic proteins.
NDA/BLA:
505(b)(2) – single study therapeutic equivalent (biosimilar)
ANDA – interchangeable
OTC Monograph

4. Food, Dietary Supplement, Cosmetics
Food: articles used for food or drink for man or other animals
Dietary Supplement: a vitamin, mineral, an herb or other botanical, an amino acid, or a dietary substance to supplement the diet by increasing the dietary intake.
Cosmetics: articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance. Does not include soap.
May market so long as company does so in conformance with the requirements.
Burden on FDA to determine a safety or non-compliance issue.

5. Foods, Dietary Supplements, Cosmetics
Keep up to date on regulatory reports and notices to industry on changes
Enforcement discretion is key
Companies may take actions when there is an issue;
Be compliant in all matters of marketing

6. Lessons Learned- Dietary Supplements
Dietary supplements do not need FDA approval prior to marketing; FDA’s role is post-marketing
FDA is “concerned” with the safe use of dietary supplements IF promoted for health benefits
may not claim to treat or cure disease or alleviate disease symptoms
FDA is “concerned” with dietary supplements if manufacturer does not report serious adverse events reported to them by consumers or health care professionals

7. Medical Devices Diagnoses, cures, lessens, treats, or prevents disease
Affects the function or structure of the body
Does not achieve primary intended purposes through chemical action

8. Medical Devices, continued
Class I – low risk of harm, exempt from regulatory process except compliance with general controls.
Class II – more complicated, requires special controls for labeling, guidance, tracking, design, performance standards, and postmarket monitoring. Most requirement premarket notification 510(k).
Class III – sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Most require premarket approval.
New world of “waived” devices – certain Mobile Medical Applications and Wellness devices.

9. Focus On Current Requirements-Devices
Classification of your device
Predicate device(s)
Final draft labeling
Specifications including engineering drawings, photos, etc.
Performance data such as bench, animal, or clinical testing (if applicable)
Sterilization information (if applicable)
Guidance document(s) specific to your device type, if it exists

10. Components of a 510(k) Filing
Table of Contents
510(k) Acceptance Checklist
Statement of Indications for Use
510(k) Summary or Statement
Truthful and Accurate Statement
Proposed Labeling
Includes all labeling, package inserts, service manuals,
instructions for use, advertising and/or promotional materials.
Specifications
Narrative description of the device.
Substantial Equivalence Comparison
Performance Data

11. FDA Review- Devices Keys to success:
Follow predicate(s) as close as possible
Obtain the 510Ks – Online from FDA or FOIA.gov
Indication for use critical
All venues for marketing should be consistent with label and materials filed with the agency
Compliance critically important
Consistency in all sections of the filing is critical
FDA will use an acceptance checklist to ensure completeness and determine whether application is ready for substantive review

12. FDA Review– Devices Issues Checklist
Establishment Registration (and yearly fee)
User fee for filing (small business lower fee)
Timelines for responses – within 90 days of filing
Responses are required within 180 days of receipt of deficiencies in the filing

13. Lessons Learned- Devices
FDA is generally correct – stay up to date
A response asking for more information is not the end of the world – respond politely and completely
Keep track of timeliness

14. Lessons Learned- Devices
Resources on the FDA website provide a good roadmap on various components of the filing
FDA hosts monthly webinars to allow public to hear and speak to senior FDA officials

15. What is FDA Basics for Industry?
Aims to make basic information about the regulatory process more accessible to industry in a user- friendly format.

16. FDA Fundamentals
Provides the public with a guide to the Agency’s resources
Information clearinghouse on approval processes, contact information, FOIA requests, etc.

17. Small Business Contacts
Center for Biologics Evaluation and Research (CBER) Office of Communication, Outreach and Development (OCOD) Division of Manufacturers Assistance and Training (DMAT) Manufacturers Assistance and Technical Training Branch(MATT) Phone: ;
Center for Drug Evaluation and Research (CDER) Office of Communications Division of Drug Information (DDI) Brenda Stodart, PharmD CDER Small Business and Industry Assistance (CDER SBIA) Phone: ;
Center for Devices and Radiological Health (CDRH) Office of Communication and Education (OCE) Division of Industry and Consumer Education (DICE) Phone: ;
Center for Food Safety and Applied Nutrition (CFSAN) Division of Education and Communication Information Center Branch, HFS-9 Food and Cosmetic Information Center Phone: ; Online Form

18. REMEMBER
FDA is the name of the Agency – but employees are empowered to review issues
Most Commissioners only in office 2-3 years
Commissioner Califf sworn in February 2016
Agency will be adding hundreds of new employees in near term to fill vacancies
Consistency in interpretation may be difficult
Competitors will complain about non-compliant competitors