Agency IQ

AUGUST 23, 2024

The office, which is responsible for directly reviewing and regulating medical devices and diagnostics, was established under a major restructuring of CDRH in 2018-2019 as part of CDRH’s “Total Product Lifecycle (TPLC)” approach. OPEQ is organized into eight “Offices of Health Technology” (OHTs), which are structured by therapeutic area (e.g.,

FDA 40

FDA Laboratories Regulations Clinical Trials 40

Drug Target Review

OCTOBER 3, 2024

3 This change signals a major shift away from animal use in drug safety regulation and encourages the use of alternative methods like organ-on-chip or other animal-free technologies. FDA no longer needs to require animal tests before human drug trials [Internet]. 1975 Aug;256(5517):495–7. Antibodies to watch in 2024.

Molecular Biology 52

Molecular Biology Pharmacokinetics Laboratories Animal Testing 52

The Pharma Data

AUGUST 16, 2020

The Medical School Council (led by the heads of UK medical schools) and the regulator, the General Medical Council, say they are putting plans in place to improve the situation. Hundreds of other UK medical students have signed petitions demanding teaching that better reflects the diversity of the country. Life-or-death signs.

Medical Schools 52

Medical Schools Doctors Drug Trials Government 52

Codon

JANUARY 21, 2024

The European Medicines Agency (EMA) is similar in this regard, although interestingly, that’s not the case in the United Kingdom, where regulators are not so directly involved in assessing a challenge study beforehand. There have been deaths in phase 1 medical and drug research among healthy participants.

Vaccine 110

Vaccine Trials Disease Treatment 110

Codon

MARCH 14, 2023

” About 6% of all mouse genes are regulated in sex-specific ways. The FDA used to require animal tests before a human drug trial could proceed; they reversed that decision in January. .” Other scientists have said much the same thing since at least 2018. A third experiment found no effect.

DNA 52

DNA Laboratories Engineering Animal Testing 52

Agency IQ

FEBRUARY 2, 2024

Diagnostics landscape analysis: Key issues and a look ahead at 2024 Diagnostic regulation in the U.S. Following significant policy proposals in recent years, 2024 is gearing up to be a profoundly impactful year for diagnostics developers and the policymakers who regulate them. is a constantly evolving topic. In the U.S., In the E.U.,

FDA 40

FDA Laboratories Regulations Production 40

Alta Sciences

JULY 31, 2024

Discover how drug developers, researchers, and regulators are ensuring this happens. Tags Clinical Trials Weight 15 Image Thumbnail_diversity in clinical trials_VAbutton.jpg Synopsis Representation and inclusion of various minority groups is crucial for medical research.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Pharmacokinetics 52

The Pharma Data

MAY 17, 2021

Regeneron resumes enrollment in lymphoma drug trials ( Reuters ). Incyte’s vitiligo treatment meets main goal in late-stage trial ( Reuters ). EU Medical Device Regulation May Spur Litigation Uptick ( Law360 ). Trump tax law cut what US drugmakers owed. BioPharmaDive ).

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Trials Vaccine FDA Biosimilars 52