WASHINGTON (March 4, 2014) - Holland & Knight partners Michael Gaba, Michael Werner and William Gould have written a portfolio for Bloomberg BNA entitled Life Sciences Compliance: A Pre-Market and Post-Market Road Map.
The portfolio analyzes the full range of federal regulations with which pharmaceutical, biotechnology and medical device must comply. The portfolio serves as a practical guide for life sciences attorneys regarding compliance with the FDA's Federal Food Drug and Cosmetic Act, and its implementing regulations, as well as the Physician Sunshine Act and HIPAA regulations. The authors also address how to avoid liability under the False Claims Act, the Anti-Kickback Statute and the Foreign Corrupt Practices Act.
Mr. Gaba, the lead author for the portfolio, is the Federal Policy Leader of the firm's national Healthcare & Life Sciences team. Mr. Gaba counsels and represents medical device and biotech companies before the FDA on get-to-market regulatory strategies as well as the full range of post-market surveillance and enforcement issues, and before CMS on coverage, coding and reimbursement strategies.
Mr. Werner provides legal, legislative, regulatory, and reimbursement advice for clients in FDA-regulated industries. He focuses on FDA regulations regarding drug/biologic review and approval, supply chain and distribution issues, regulations governing clinical trials, as well as conflicts of interest and other bioethics issues arising from research and uses of new technologies.
Mr. Gould represents companies in the pharmaceutical and medical device industry in litigation and internal investigations involving the False Claims Act, the Foreign Corrupt Practices Act and the federal Anti-Kickback Statute. He also provides counsel regarding risk management to companies in the health care field.
The portfolio is available from Bloomberg BNA.
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