What's Happening in Software and Device Regulation – FDA Watch
Shelly and Wayne chat with Jennifer Newberger, Director at Hyman, Phelps & McNamara, and Michael Gaba, Vice Chair of the FDA practice at Polsinelli. You’ll hear their thoughts on how to interact with FDA officials under the new administration; anticipated changes in the review and approval of PMAs, 510ks, and de novo applications; clinical trial requirements for SaMD; and much more.
Headlines
Pharma: FDA approves Merilog, a biosimilar to Novolog for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus
Devices: Lobby Urges HHS To Rethink Trump’s FDA Cuts
Food: 2.4 Million Cases of Popular Granola Bars Recalled Due to ‘Potential Presence of Metal’
Cosmetics: PCPC President & CEO Tom Myers Discusses how the Beauty Industry is Innovating with AI, Sustainability, and Transparency
Resource Links
Pharma: FDA issues warning letter to Indian drug manufacturer
Devices: Associated Press: FDA moves to rehire medical device staffers fired only days earlier
Cosmetics: CosmeticsDesign USA: FDA’s proposed formaldehyde ban remains unpublished as industry awaits clarity
About Our Guests
Jennifer Newberger
Jennifer Newberger has spent nearly 20 years providing counsel to medical device manufacturers of all sizes, across all product types, throughout the product lifecycle. Her primary objective is to help clients achieve their business objectives while maintaining a strong record of FDA compliance. To this end, Ms. Newberger assists clients in matters including development of regulatory strategy, preparation of regulatory submissions, development and implementation of policies, procedures, and compliance programs, review of advertising and promotional materials, and responding to enforcement matters from FDA or other agencies, including the Department of Justice. She also supports clients in mergers and acquisitions on both the buyer and seller side, conducting FDA-focused regulatory due diligence and advising on applicable contract and transaction matters as well as public filings.
In addition to preparation of pre-submission and submission materials for FDA, Ms. Newberger assists clients in responding to inquiries from FDA during the review process and participating in meetings with clients to address FDA concerns. She also advises clients on post-market compliance matters, including complaint handling, reporting of adverse events and medical device malfunctions, field actions including recalls, promotional review, and compliance with the requirements of the quality system regulations. A key part of this work includes advising clients as to when notification to the agency is needed with respect to product changes, malfunctions, adverse events, or other product concerns. She has supported clients in negotiating agreements involving the FDCA and the False Claims Act, responding to FDA inspectional observations and Warning Letters, and conducting internal investigations.
Michael Gaba
Michael Gaba provides strategic FDA regulatory, Medicare policy, and federal relations counsel to an array of companies developing a variety of products in the life sciences space, whether traditional medical devices, digital health-based products, biotechnologies, biologic-device combinations, or pharmaceuticals. His primary goal is to bring companies to market and then help them remain there in the most efficient and effective manner possible.
Working as an extension of each company’s legal and business teams, Michael draws on nearly 30 years of experience to navigate the FDA pre-market regulatory pathways, counsel companies on FDA post-market compliance matters, and resolve Medicare coverage, coding, and reimbursement disputes with the Centers for Medicare and Medicaid Services. By using his FDA and CMS experience during the product development phase, Michael is able to help maximize companies’ opportunities to be appropriately compensated in the proper treatment venues, whether a physician’s office, hospital outpatient or inpatient departments, ambulatory surgical centers or home care.
FDA Watch Podcast 