A “Successful” FDA Submission: Key Components Needed Nancy Taylor, Shareholder, Greenberg Traurig LLP taylorn@gtlaw.com 202-331-3133 March 3, 2016

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

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

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.

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

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

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

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.

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

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

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

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

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

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

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

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

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: 800-835-4709; Email: Industry.Biologics@fda.gov 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: 866-405-5367; Email: CDERSmallBusiness@fda.hhs.gov Center for Devices and Radiological Health (CDRH) Office of Communication and Education (OCE) Division of Industry and Consumer Education (DICE) Phone: 800-638-2041; Email: DICE@fda.hhs.gov Center for Food Safety and Applied Nutrition (CFSAN) Division of Education and Communication Information Center Branch, HFS-9 Food and Cosmetic Information Center Phone: 888-723-3366; Online Form

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