JURIST
JANUARY 4, 2025
India’s Ministry of Electronics and Information Technology (MeitY) on Saturday released draft rules in furtherance of the Digital Personal Data Protection (DPDP) Act, sparking significant debate regarding the rules’ implications on data privacy rights.
FDA Law Blog
FEBRUARY 13, 2025
The final guidance hasnt changed much from the draft guidance with respect to the type of modifications FDA considers applicable for a PCCP and the required components of a PCCP (see our prior blog post on the draft guidance here ). FDA may request additional information during the review of the PCCP.
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FDA Law Blog
FEBRUARY 27, 2025
While ICH E6(R3) was still in the development phase, the FDA released a draft guidance in May 2023 in the form of the draft ICH E6(R3). Livornese As anticipated, the International Council for Harmonization (ICH) published the Good Clinical Practice (GCP) guideline E6(R3) Principles and Annex 1 on January 6, 2025.
FDA Law Blog
MAY 8, 2023
Javitt — FDA recently published a long-awaited draft guidance aimed at reducing the need for prior FDA authorization of modifications to artificial intelligence/machine learning (AI/ML)-enabled device software functions (ML-DSFs). The draft guidance follows the December 2022 enactment of the Food and Drug Omnibus Reform Act of 2022 (FDORA).
FDA Law Blog
MAY 4, 2023
Cato — On May 2nd, FDA released a new draft guidance with recommendations for decentralized clinical trials (DCTs) for drugs, biologics, and devices. This draft guidance builds on recommendations that FDA initially developed early in 2020, in response to the COVID-19 challenges (see our blog post on these recommendations here ).
FDA Law Blog
JUNE 10, 2024
In an effort to clarify for industry and alleviate some of the stress associated with these activities, last week the FDA issued a draft guidance aimed at providing recommendations on how to handle inspections under FDA’s Bioresearch Monitoring (BIMO) program. 11-12 of the guidance for a list of these resources).
Knackly
MARCH 18, 2025
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