Skip to main content Skip to search Skip to main navigation

FDA: Patrizia Cavazzoni, M.D., to lead CDER

On 12 April 2021, Dr Janet Woodcock, acting head of the US FDA, announced Dr Patrizia Cavazzoni's new role as director of CDER.

She posted the announcement on her official Twitter account @DrWoodcockFDA. Last year, Cavazzoni succeeded Woodcock as acting head of CDER. As previously reported, Woodcock became committed to Operation Warp Speed (OWS) at that time. 

Cavazzoni joined FDA in January 2018 as acting director of CDER. Prior to that, she held leadership positions at Pfizer as well as other pharmaceutical companies and served as a psychiatrist. 

While Cavazzoni has now been appointed from acting to permanent director, a possible designation of Janet Woodcock as FDA commissioner remains open. 

With President Biden already three months into office, calls are growing louder for a definitive appointment of FDA leadership in the near future.


Source:

Twitter @DrWoodcockFDA

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:

FDA: Draft Guidance on Responding to Form 483 Observations

FDA: Draft Guidance on Responding to Form 483 Observations

The US Food and Drug Administration (FDA) has issued a draft guidance on responding to Form FDA-483 observations following drug CGMP inspections. The document provides recommendations on how manufacturers should structure their responses and what information they should include.
Read more
Which Quality and Process Parameters must Typically be Taken into Account During Process Validation for Terminally Sterilized Products?

Which Quality and Process Parameters must Typically be Taken into Account During Process Validation for Terminally Sterilized Products?

Here's the answer:
Read more
Veterinary GMP 2026: The New Regulatory Framework

Veterinary GMP 2026: The New Regulatory Framework

Implementing Regulations (EU) 2025/2091 and 2025/2154 consolidate the GMP requirements for veterinary medicinal products into a distinct and legally binding framework for the first time. While establishing regulatory independence for the veterinary sector, they remain substantively aligned with the EU GMP Guide.
Read more
Team-NB: Opportunities and Concerns in the MDR/IVDR Revision

Team-NB: Opportunities and Concerns in the MDR/IVDR Revision

Team-NB, the European association of medical device Notified Bodies, sees the proposed MDR and IVDR revision as an opportunity to improve efficiency, transparency and predictability in conformity assessment.
Read more
EMA: GMP Documentation for the Sterilisation of an API

EMA: GMP Documentation for the Sterilisation of an API

The EMA Q&A on the quality of medicines has been updated with a new question: “What kind of GMP documentation is required for an API manufacturer performing sterilisation of an active substance?”

Read more
EMA: Updated Q&A on OOS Batches of ATMPs

EMA: Updated Q&A on OOS Batches of ATMPs

The EMA has revised its questions and answers on the use of out-of-specification (OOS) batches of authorised cell- and tissue-based ATMPs (“Questions and answers on the use of out-of-specification batches of authorised cell/tissue-based ATMPs”, Rev. 1, 2026).
Read more
Previous
Next