Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. An updated Unified Agenda: The Unified Agenda is the U.S.

FDA 40

FDA Science Regulations Production 40

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.” During the COVID-19 pandemic, the number of opioid-involved deaths climbed sharply, with mortality rates increasing by 38% between 2019 and 2020.

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40

Alta Sciences

JULY 31, 2024

Pancreatic cancer, for example, does not affect all populations equally and, between 2000 and 2020 , African Americans in the United States persistently had a 19% higher incidence of pancreatic cancer when compared with other racial groups. Discover how drug developers, researchers, and regulators are ensuring this happens.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Drug Development 52

Agency IQ

OCTOBER 20, 2023

.” Interchangeable products can be substituted for the reference product at the pharmacy level, without prescriber intervention, within state and local regulations. Pharmacodynamic (PD) alternatives: Another internal project, this time from CDER’s Office of Clinical Pharmacology (OCP), was presented by YOW-MING WANG, associate director.

Science 40

Science Biosimilars FDA Production 40

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

BY RACHEL COE, MSC | NOV 27, 2023 8:24 PM CST FDA’s transition away from public health emergency (PHE)-related guidance documents The Covid-19 Public Health Emergency (PHE) was activated on January 31, 2020. The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion.

FDA 40

FDA Clinical Trials Vaccine Trials 40

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Clinical Trials Regulations 40

The Pharma Data

FEBRUARY 8, 2021

[v] ERLEADA ® is being studied in five Phase 3 clinical trials. Accessed December 11, 2020. iv] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for Prostate Cancer V.3.2020. Accessed December 2020. [v] Accessed February 2020. [vi] Prescribing Information, October 2020.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Therapies 52

Drug Target Review

NOVEMBER 27, 2024

Advanced techniques like liquid chromatography tandem mass spectrometry (LC-MS/MS) and Meso Scale Discovery (MSD) provide the kind of comprehensive and reliable data increasingly favoured by regulators, yet many researchers continue to rely exclusively on enzyme-linked immunosorbent assay (ELISA). Clinical Pharmacology & Therapeutics.

Drug Development 52

Drug Development Regulations Laboratories FDA 52

Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

Regulations 40

Regulations FDA Science Production 40