Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

Science 40

Science FDA Clinical Trials Pharmacy 40

Drug Discovery World

AUGUST 10, 2022

Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic. Measuring the pharmacokinetics of CAR T cells.

Therapies 246

Therapies Virus Treatment Engineering 246

The Pharma Data

DECEMBER 15, 2020

The researchers regulated the abnormal immunological memory processes found in these patients. Daratumumab already is approved for the treatment of multiple myeloma. The secondary outcome involves pharmacokinetic endpoints. The human monoclonal antibody targets specific immune plasma cells. Bioelectronic Platform.

Disease 52

Disease Clinical Trials Small Molecule Trials 52

FDA Law Blog: Biosimilars

MAY 21, 2024

We wondered how given that HHS and the Drug Enforcement Administration (“DEA”) conducted eight-factor scheduling analyses in 2016, concluding that there was “no substantial evidence that marijuana should be removed from Schedule I.” 12, 2016) ; Denial of Petition to Initiate Proceedings to reschedule Marijuana, 81 Fed. 12, 2016).

Regulations 69

Regulations FDA Licensing Licensing 69