[2] She joined the FDA in 1986, and has held a number of senior leadership positions there, including terms as the Director of Center for Drug Evaluation and Research (CDER) from 1994 to 2004 and 2007 to 2021.

She informs the United States Congress and other government bodies about the FDA and its concerns, helping to develop policy recommendations and legislation.

As Director of the Office of Therapeutics Research and Review (1992–1994), Woodcock covered the approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis.

It’s the intersection of science and medicine and law and policy.Woodcock informs Congress and other government bodies about the FDA and its concerns in order to guide policy recommendations and legislation.

How I wish others in the administration showed the same vigor, responsiveness, and leadership.”In 2000 Woodcock introduced the concept of risk management to the FDA's analysis of drug safety.

FAERS helps to track adverse event and medication error reports from health care professionals (physicians, pharmacists, nurses and others) and consumers (patients, family members, lawyers and others).

It is used in combination with MedWatch and the Vaccine Adverse Event Reporting System (VAERS) is to identify potential safety concerns.

Woodcock launched the Sentinel Initiative in 2008 in response to passage of the Food and Drug Administration Amendments Act of 2007 ("FDAAA").

[3][27][28] The Sentinel System draws on existing databases of private health care insurers and providers to actively monitor for safety issues as they are developing, rather than relying on later third-hand reports.

[33][34] On January 27, 2021 a coalition of 28 public health groups and opioid crisis organizations sent a letter to the Biden Administration regarding Woodcock's position as Acting Commissioner of the FDA.

The letter said in part that "as the Director of the FDA’s Center for Drug Evaluation and Research (CDER) for more than 25 years, Dr. Woodcock presided over one of the worst regulatory agency failures in U.S.