Clinical Development, Drug Development, Regulations and White Paper

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Clinical Development

Drug Development

Regulations

White Paper

Evolution of Clinical Operations Drives FSP Staffing Models to the Forefront

PPD

OCTOBER 2, 2024

Efficient and effective clinical operations are the backbone of successful clinical trials, and today’s biopharmaceutical, biotech and medical device organizations have a range of options to meet their needs in this critical area. In many cases, higher levels of sponsor oversight are even required by regulation.

Clinical Trials

Clinical Trials Clinical Development Clinical Research Trials

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The workshop is also discussed in Cell & Gene here and here. Other Questions.

Therapies

Therapies Engineering Production FDA

Drug Discovery Digest

Evolution of Clinical Operations Drives FSP Staffing Models to the Forefront

OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

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