Sandra Kweder, M.D., Former Deputy Director of FDA-OND, Joins Firm

Sandra Kweder, M.D., a former senior official with the Food and Drug Administration (FDA) has joined the company as Principal, Drug & Biological Products. Greenleaf Health, an ELIQUENT Life Sciences Company, is a leading consulting firm for companies regulated by the FDA.

Dr. Sandra Kweder is an internal medicine expert with more than 30 years of experience in U.S. and international medical products regulation and policy.

Prior to joining Greenleaf, Sandy served for six years as Deputy Director of the FDA’s Europe Office and Liaison to the European Medicines Agency (EMA), first in London and later in Amsterdam, working to strengthen international collaboration across all areas of FDA regulation, especially medical products. She launched new engagements with the EMA in areas including labeling and study of drugs in pregnancy, patient engagement strategy, rare disease product development, and an invigorated parallel scientific advice program. Upon returning to the U.S., she provided strategic direction and subject matter expertise to FDA leadership as Senior Medical and Regulatory Advisor in the Office of Global Strategy and Policy.

Prior to her work in Europe, Sandy spent nearly 14 years as the Deputy Director of CDER’s Office of New Drugs. She guided OND through a phase of substantial maturation between 2002 and 2016, as the prescription drug user fee program (PDUFA) grew and CDER strengthened review standards and practices to incorporate scientific innovation and emerging drug development approaches such as patient-reported outcomes in clinical trials. She also launched and led, for 10 years, the FDA’s modernization of its approach to labeling for and studying medicines in pregnancy and lactation.

Sandy joined the FDA in 1988 as a medical officer in the Division of Antiviral Drug Products, newly established to address the urgent need for treatments for HIV/AIDS. For 33 years Sandy served in the U.S. Public Health Service, rising to the rank of Rear Admiral before retiring from the service in 2013.

As Principal, Drug and Biological Products, with Greenleaf Health, Sandy offers broad expertise accrued through multiple senior leadership roles at the FDA, where she oversaw significant regulatory developments during periods of transformation in the landscape of science policy and public health.

“It was difficult to leave FDA, so full of dynamic, intelligent, committed experts – I never had a dull moment in over 30 years. I am fortunate now, though, for an opportunity to carry that energy and integrity to Greenleaf and continue to collaborate with trusted and admired former FDA colleagues,” said Dr. Kweder.

Learn more about Dr. Kweder’s experience and her role at Greenleaf Health.

About Greenleaf Health

Greenleaf is guided by experts with a combined total of more than 300 years of FDA experience. Sandy and Don join a distinguished group of professionals at Greenleaf who previously served as leaders throughout the Agency, including: John Taylor, former FDA Counselor to the Commissioner and Principal Deputy Commissioner; Dr. Daniel Schultz, former Director of the FDA’s Center for Devices and Radiological Health (CDRH); Dr. Karen Midthun, former Director of the FDA’s Center for Biologics Evaluation and Research (CBER); Dr. John Jenkins, former Director of the Office of New Drugs for the FDA’s Center for Drug Evaluation and Research (CDER); Dr. Robert Meyer, former Director of CDER’s Office of Drug Evaluation II; Heather Rosecrans, former Director of CDRH’s 510(k) staff; David Elder, former Director of the FDA’s Office of Regional Affairs and Office of Enforcement; Cynthia Schnedar, former Director of CDER’s Office of Compliance; and Mark Kramer, former Director of CDER’s Office of Combination Products.

Greenleaf Health provides strategic and technical guidance to pharmaceutical, biotechnology, and medical device companies researching, developing, and manufacturing innovative solutions to pressing global public health challenges. Greenleaf’s robust blend of technical skill and FDA institutional knowledge enables the firm to provide reliable, objective guidance to companies developing medical products for the U.S. market.