Donald Segal practices primarily in food, drug and medical device regulation. Mr. Segal provides counsel to pharmaceutical, medical device, biologic, food and cosmetic companies regulated by the FDA. He has practiced food and drug law, health care law and administrative law for over 25 years in national law firms and at the FDA, where he served as Associate Chief Counsel.
Mr. Segal focuses on providing strategic advice, and legal and regulatory counsel to a variety of product manufacturers, distributors, hospitals and service providers regarding market entry issues and compliance matters involving marketed products. For example, he assists clients in responding to preparing pre-market submissions and the review of labeling and advertising. He advises clients on recalls, adverse events reporting and current good manufacturing practices (GMPs). Mr. Segal has assisted clients with responding to inspectional findings and warning letters, preparing regulatory sections of securities filings, and preparing and negotiating licensing and contractual agreements. He has also represented companies in litigation regarding injunctions, seizures and intellectual property issues.
- Represented financial institutions in their due diligence and regulatory analysis of potential acquisitions of medical device, drug and food companies.
- Represented a medical device company regarding a denial of a 510(k) submission, and, after meeting with FDA and revising the submission, securing FDA clearance.
- Represented a major food manufacturer in the conduct of a recall and resolution of subsequent insurance and product liability claims.
- Represented a drug company in petitioning FDA to expand the scope of an OTC drug monograph.
- Represented a biomedical company in resolving 510(k) and inspectional deficiencies.
- Represented a manufacturer of medical and laboratory instruments in developing a strategy to seek new indications.
- Submitted complaints to FDA regarding misleading competitor advertising and promotion.
- Evaluated the regulatory implications of health care-related software and software-related service offerings.
- Provided advice regarding corporate integrity agreements.
- Provided advice regarding food additive petitions and food standards of identity.
This advisory discusses the U.S. Food and Drug Administration (FDA) issuing its much anticipated and long-awaited Final Rule on the “Gluten-Free Labeling of Foods”—more than six years after the agency published its Proposed Rule in January 2007. The final rule seeks to answer many of the lingering questions from both food manufacturers and those consumers who suffer from celiac disease by establishing a standardized federal definition of the term “gluten-free” across the food industry. Although the final rule becomes effective on September 4, 2013, companies will have one year to comply with the regulation until August 5, 2014.
August 5, 2013
Last week, FDA released a draft guidance document entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements.” The guidance addresses relationships between the entities that introduce a drug into interstate commerce (the “Owner”) and third parties that perform some or all of the manufacturing operations for the product (the “Contracted Facilities”). The guidance describes how Owners and Contracted Facilities can use Quality Agreements to define responsibilities associated with manufacturing activities in a manner that is consistent with regulatory requirements.
June 3, 2013
On February 25, 2013, the U.S. Food and Drug Administration (FDA) issued a proposed rule amending its regulations to update the standards for FDA acceptance of data from clinical studies. FDA is proposing to amend these regulations so that acceptance of data from clinical studies is consistent across all types of device submissions.
March 4, 2013
On January 22, 2013, the U.S. Food and Drug Administration (FDA) published its final rule implementing current good manufacturing practice (CGMP) requirements for combination products, which will take effect on July 22, 2013. FDA promulgated the rule in response to comments the agency received on its CGMP Guidance for Combination Products that described the need to develop a clear regulatory framework to account for the variety of combination products that can contain drug, device and/or biologic components.
January 24, 2013
On December 31, 2012, FDA issued two guidance documents detailing the agency’s approach to reviewing the completeness of medical device applications reviewed by the Center for Devices and Radiological Health (CDRH). The two guidance documents cover PMA submissions, Acceptance and Filing Reviews for Premarket Approval PMAs) (“PMA Guidance”), and 510(k) submissions, Refuse to Accept Policy for 510(k)s (“510(k) Guidance”). Both of these documents superseded previous FDA guidance on evaluating whether medical device applications were complete for filing.
January 14, 2013
- Food and Drug Law Institute
- Regulatory Affairs Professionals Society
- United States Supreme Court Bar of the United States
- Bar of the United States Court of Appeals for the District of Columbia
- American Health Lawyers Association