DrugBank

FEBRUARY 9, 2023

Check out previous Trends & Insights Spotlights Academic User Spotlight Subhajit Dutta 1,2 & Ted Natoli 3 Laboratory of Cellular Differentiation & Metabolic Disorder, Department of Biotechnology, National Institute of Technology Durgapur, India. 2 Cancer Program, Broad Institute of MIT and Harvard, USA.

Clinical Pharmacology 52

Clinical Pharmacology Molecular Biology DNA Licensing 52

Agency IQ

MAY 3, 2024

Beyond litigation, expect that CDRH Director JEFF SHUREN could be called before House legislators who have already expressed displeasure at the rule.

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

JUNE 16, 2023

Perhaps the most important addition to FDA’s agenda is a proposed rule intended to clarify that Laboratory Developed Tests (LDTs) are to be regulated as medical devices under the Federal Food, Drug and Cosmetic Act (FD&C Act). Of those 51, just four are new to the Agenda, having never before been made public.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

SEPTEMBER 29, 2023

July 2023 (Under OIRA Review) Medical Devices; Laboratory Developed Tests (Proposed Rule) This proposed rule would propose to amend the Food and Drug Administration’s regulations to make explicit that laboratory developed tests (LDTs) are devices under the Federal Food, Drug, and Cosmetic Act.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

DECEMBER 1, 2023

Comments on LDT Proposed Rule: On December 4, the comment period on the FDA’s Laboratory Developed Test proposed rule will close, and we will get a fuller picture of the extent to which the life sciences industry opposes the FDA’s proposal. Whatever the agency decides could result in new lawsuits or negative political attention.

FDA 40

FDA Science Regulations Production 40