U.S. Food & Drug Administration: Draft Guidance for Industry and Other Interested Parties
Date: January 23, 2025
The U.S. Food and Drug Administration has issued its first guidance on the use of Artificial Intelligence (AI) for the development of drug and biological products.
This draft guidance, titled ‘Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products,’ has been put together to provide recommendations on the use of AI intended to support a regulatory decision about a drug or biological product’s safety, effectiveness, or quality.
Read here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-artificial-intelligence-support-regulatory-decision-making-drug-and-biological
Explore More News
ICON to be Premier & Award Sponsors for ACDM20
The Association for Clinical Data Management are delighted to announce that ICON will be . . .
Read More
New Online Learning Course – Understanding Laboratory Data
The Association for Clinical Data Management is delighted to launch their 4th online . . .
Read More
Nominations now open for ACDM Awards 2020
The Association for Clinical Data Management are delighted to announce the opening of . . .
Read More
Phastar announced as Networking Sponsor for ACDM20
The ACDM are delighted to announce that Phastar are to be Networking & Conference . . .
Read More
ACDM20 Dates & Venue
The ACDM are delighted to announce that ACDM20, the 2020 ACDM Annual Conference will take . . .
Read More
Launch of Online Training from ACDM
The Association for Clinical Data Management is delighted to announce the launch of Online . . .
Read More
ACDM 2019 Awards Finalists
The Association for Clinical Data Management are delighted to announce the finalists for . . .
Read More
Castor EDC to Sponsor ACDM19
The Association for Clinical Data Management (ACDM) are delighted to announce that Castor . . .
Read More
Danone Nutricia Research to Sponsor ACDM19
The Association for Clinical Data Management (ACDM) are delighted to announce that . . .
Read More
ACDM19 Conference Programme
The Association for Clinical Data Management is delighted to announce the Full Programme . . .
Read More
Record Number of Abstracts Submitted for ACDM19
The deadline for Abstracts for ACDM19 passed on the 30th September and the Association for . . .
Read More
Phastar Sponsor ACDM19
The Association for Clinical Data Management are delighted to announce that PHASTAR are . . .
Read More
