An Extensive Breakdown of the Pharmaceutical and Biologics Landscape – FDA Watch
Wayne chats with Daniel Kracov, Partner and Chair of the Life Sciences Industry Group at Arnold & Porter, and Dr. Gayatri Rao, Director at Hyman, Phelps & McNamara. You’ll hear their thoughts on Operation TrialBlazer; what’s been happening lately with CBER and CDER; the latest in rare diseases and orphan drugs; developments in cell and gene therapy; the Plausible Mechanism Framework; the situation with China and global drug development; and much more.
Headlines
Acting FDA Commissioner Kyle Diamantas releases new strategic framework built around four public health priorities
Pharma: FDA makes 14 CRLs available, rejecting drug applications, despite previously pausing real-time CRL transparency initiative
Devices: FDA clears Software as a Medical Device with patient-facing LLM
Food: FDA delays publication of proposed rule to eliminate the GRAS pathway
Cosmetics: PCPC urges U.S. Trade Representative to ensure cosmetics and personal care products are prioritized in proposed U.S.-China Board of Trade
Resource Links
FDA launches new adverse event reporting tool
Pharma: FDA proposes rule intended to modernize drug manufacturing registration
Cosmetics: From Cosmetics Business, Opinion: How the FDA’s July peptide review will raise the stakes for beauty brands
About Our Guests
Daniel Kracov
Dan Kracov is chair of the firm’s Global Life Sciences Industry group, which was honored by Law360 in 2020 and 2022 as a “Life Sciences Practice Group of the Year.” For decades, he has been one of the foremost Food and Drug Administration lawyers in the country, and his expertise in critical regulatory matters has been widely recognized by Chambers, the Legal Times, Best Lawyers in America, and many other publications. Most recently, Dan received the Food and Drug Law Institute (FDLI) Distinguished Service and Leadership Award. A particular focus of his practice is assisting pharmaceutical, biotechnology, medical device, and diagnostic companies, including start-up companies, trade associations, and large manufacturers, negotiate challenges relating to the development, approval, and marketing of FDA-regulated products.
In addition to day-to-day counseling on regulatory and compliance strategies and concerns, Dan regularly handles product and compliance-related government and internal investigations, the development of global corporate compliance programs, and due diligence in financings, mergers, and acquisitions. He also has a widely recognized experience in biomedical public policy matters, including Congressional investigations and advising on FDA-related legislation.
Dr. Gayatri Rao
Gayatri Rao, M.D., J.D., M.B.E., advises biotechnology and pharmaceutical companies on FDA regulatory strategy and medical product development from early translation through approval, with a particular focus on rare diseases. As a seasoned FDA and biotechnology executive, she brings firsthand experience in regulatory decision-making and product development to provide practical, business-focused counsel. Drawing on her unique combination of legal, medical, and ethical expertise, she helps clients navigate complex regulatory challenges with a multidisciplinary perspective.
Prior to joining the firm, Dr. Rao served as Chief Development Officer and later Chief Regulatory Officer at Rocket Pharmaceuticals, a commercial-stage gene therapy company focused on rare, life-threatening diseases. She led the end-to-end development of multiple gene therapy programs, guiding products from early translation through clinical development and regulatory submissions, including the FDA approval of KRESLADI™ (marnetegragene autotemcel).
Earlier in her career, Dr. Rao spent nearly a decade at the FDA, including seven years as the Director of the Office of Orphan Products Development (OOPD). In that role, she oversaw the Orphan Drug Designation Program, during which approximately 1900 drugs received orphan drug designation and 250 were granted orphan exclusivity. She spearheaded implementation of the Rare Pediatric Disease (RPD) Priority Review Voucher Program (PRV), issuing the first 100 RPD designations that ultimately led to the first 9 RPD PRVs. She also played a leading role in shaping orphan drug policy and fostering international regulatory partnerships. She joined FDA an Associate Chief Counsel in FDA’s Office of Chief Counsel, where she advised on combination products, medical devices, human subject protection, and other complex regulatory matters.
Dr. Rao began her career in the Food and Drug and Healthcare Practice Groups at a Washington, DC law firm, where she handled complex internal investigations, advertising and promotion, and manufacturing quality systems issues for life sciences companies.
Dr. Rao earned her M.D. from Rutgers New Jersey Medical School, J.D. from the University of Pennsylvania Law School, and Master of Bioethics from the University of Pennsylvania School of Medicine. She is admitted to practice in the District of Columbia and New York.
FDA Watch Podcast 