Skip to main content Skip to search Skip to main navigation

FDA: Janet Woodcock becomes acting commissioner

Dr. Janet Woodcock has been appointed as acting commissioner of the FDA. The previous commissioner, Dr. Stephen M. Hahn, stepped down from his role at the start of President Biden's term of office.

Janet Woodcock already has a 30-year career at FDA. Most recently, she led the CDER (US FDA Center for Drug Evaluation and Research). Since May 2020, she has also been responsible for leading Operation Warp Speed to support the development of COVID-19 therapeutics. Woodcock will continue to perform this function.  

As she says, she welcomes the challenge of leading FDA on a transitional basis because: 

"The FDA’s public health work is more critical than ever as we continue to fight this global pandemic." 


Sources:

FDA: Janet Woodcock 

Twitter: Janet Woodcock 

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

How is a QRM process initiated?

How is a QRM process initiated?

You can view the answer here:
Read more
FDA: Updated Pre-RFD Guidance for Combination Products

FDA: Updated Pre-RFD Guidance for Combination Products

The U.S. FDA has released an updated final guidance on preparing a Pre-Request for Designation (Pre-RFD), replacing the previous 2018 version. The revised document provides new recommendations for interacting with the Office of Combination Products (OCP) and clarifies expectations for Pre-RFD submissions.
Read more
EDQM: 9 Virtual Training Modules on Ph. Eur. and CEPs

EDQM: 9 Virtual Training Modules on Ph. Eur. and CEPs

The EDQM has introduced a modular training programme covering chemically defined active substances and medicinal products. It will take place between 1 and 12 December 2025.
Read more
 Data Integrity and Data Governance

Data Integrity and Data Governance

Data integrity is a key element in the pharmaceutical quality assurance system which has gained importance in recent years, especially from the viewpoint of the authorities. In GxP-regulated companies, managers are responsible for identifying and minimising risks to data integrity (“data governance”).

Read more
EMA Clarifies “Novel or Complex Manufacturing Process” Definition

EMA Clarifies “Novel or Complex Manufacturing Process” Definition

In its Quality of Medicines Q&A – Part 1, the EMA has clarified how “novel or complex manufacturing processes” should be interpreted for variation categories Q.II.b.1 (new/replacement finished product manufacturing site) and Q.II.b.4 (change in batch size).
Read more
EU: Environment Committee Comments on EU Regulation Regarding Critical Medicines

EU: Environment Committee Comments on EU Regulation Regarding Critical Medicines

The Environment Committee of the European Parliament has issued its opinion on the proposed EU Regulation to strengthen the availability of critical medicines. Key recommendations include fast-track permitting, simplified environmental assessments, and support for strategic manufacturing projects to boost EU production capacity.
Read more
Previous
Next