Drug Discovery World

NOVEMBER 29, 2022

This ranges from understanding disease processes and identifying possible drug targets, to organising testing, rolling out clinical trials, negotiating complex regulations and licensing and finally, treating patients. Pharmacokinetics: How the body handles drugs. Providing a broad view.

Clinical Pharmacology 130

Clinical Pharmacology Clinical Trials Drugs Drug Development 130

Agency IQ

JULY 28, 2023

FAR regulations require contracting officers to “promote and provide for full and open competition in soliciting offers and awarding Government contracts.” Industry wants its products reviewed quickly, efficiently and predictably. Without sufficient resources, the FDA is unable to do so. Read the full AgencyIQ analysis here.

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40

Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

Science 40

Science FDA Trials Clinical Pharmacology 40

Agency IQ

DECEMBER 11, 2023

FDA offers a status check on its diversity in research provisions, one year post-FDORA At a workshop on FDA’s implementation of new statutory requirements for diversity in clinical research, agency and industry representatives gave a status update on implementation. FDORA also directed the FDA to convene a meeting.

FDA 40

FDA Research Clinical Trials Regulations 40

Agency IQ

FEBRUARY 2, 2024

See AgencyIQs analysis of a workshop on novel methodology qualification.] The basic structure of the document hasn’t changed, and ranges from pharmacokinetics to exploratory studies, through to guidance on pivotal trials, safety, and more. novel methodology qualification.

Clinical Trials 40

Clinical Trials Trials Treatment Production 40

Agency IQ

DECEMBER 11, 2023

Previously, burdensome side effects may have been written off as a necessary part of treatment and benefits measured in additional weeks or months of survival time; today, though, patients, clinicians, and regulators expect more. In July, a new contract notice indicated that this is an area of interest for FDA as well.

FDA 40

FDA Science Clinical Trials Trials 40