Sandra Kweder, M.D., former Deputy Director of FDA’s Office of New Drugs and Donald D. Ashley, J.D., former Director of CDER’s Office of Compliance, Join Firm

Greenleaf Health, Inc. (Greenleaf), a leading Food and Drug Administration (FDA) regulatory consulting firm, today announces that two former senior officials from the FDA’s Center for Drug Evaluation and Research (CDER) have joined the firm: Sandra Kweder, M.D., former Deputy Director of CDER’s Office of New Drugs (OND) and Deputy Director of the FDA’s Europe Office, as Principal, Drug and Biological Products, for Greenleaf Health; and Donald D. Ashley, J.D., former Director of CDER’s Office of Compliance, as Executive Vice President, Regulatory Compliance. Kweder and Ashley each bring unique subject matter expertise that expands Greenleaf’s unmatched regulatory advising capabilities.

Sandra Kweder, M.D.

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.

Donald D. Ashley, J.D.

Donald Ashley is an expert in compliance and enforcement matters and joins Greenleaf Health following a distinguished 25-year career at the FDA and the Department of Justice (DOJ), including six years as Director of CDER’s Office of Compliance at the FDA.

As Director of CDER’s Office of Compliance, Don led a staff of over 400 lawyers, scientists, consumer safety officers, pharmacists, and physicians. He oversaw development and implementation of the FDA’s entire breadth of drug compliance and enforcement measures, including for manufacturing quality, current good manufacturing practice, good clinical practice, data integrity, clinical trial oversight, pharmacovigilance, drug supply chain security, compounding, over-the-counter monograph compliance, drug import and export, and unapproved drug compliance, among other areas. Don led all drug compliance actions taken by the FDA following inspection, as well as all grants of regulatory discretion in drug shortage cases.

As an executive member of CDER’s Drug Risk Management Board, Don helped guide the Agency’s approach to some of most difficult drug safety issues over the last several years, including for nitrosamine and benzene impurities. In addition, Don served as one of a small group of senior agency officials who liaised with the generic drug industry to implement the Generic Drug User Fee Act program.

Before joining the FDA, Don spent nearly two decades at DOJ in both the Civil and Criminal Divisions, prosecuting violations of the Food, Drug, and Cosmetic Act among other criminal statutes, as well as managing and directing investigations on both a national and international level. Don earned his J.D. from Harvard Law School and an A.B., magna cum laude, from John Carroll University.

“I will be eternally grateful for having had the opportunity to serve with and learn from so many dedicated and talented colleagues during my 25-year career at FDA and DOJ. I’m excited to join the Greenleaf team and look forward to helping our clients navigate their most challenging regulatory, compliance, and enforcement matters,” said Don.

Learn more about Don’s experience and his 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.