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New FDA Draft Guidance Data Integrity For In Vivo Bioavailability And Bioequivalence Studies

Decoding The FDAs Draft Guidance On Computer Software Assurance For Medical Devices BioPharma

Regulatory Roundup: Important FDA Developments at the End of September 2022 | Mintz - Health Care Viewpoints

There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022...

Regulatory Roundup: Important FDA Developments At The End Of September 2022 - Healthcare

There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022...

Pharma 40 Software Methodologies In Biopharma Medical Devices

The life sciences industry has been using computer software validation testing methodology to validate software that is categorized to be GxP in...

FDA's Draft Computer Software Assurance Guidance Changes the Game for Quality System and Production Software Validation | King & Spalding

On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document...

FDA Issues Medical Device Production Computer Software Guidance

The FDA has issued draft guidance on computer software assurance for computers and automated data processing systems used in medical device production.

FDA Releases Guidance On Digital Health Data Acquisition In Clinical Investigations

Increasingly, digital health technologies are becoming part of the conduct of clinical trials. They cover a broad range of applications, including...

FDA Releases Guidance On Digital Health Data Acquisition In Clinical Investigations

Increasingly, digital health technologies are becoming part of the conduct of clinical trials. They cover a broad range of applications, including...