Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies. In other words, what are the risks and benefits of the product?

Clinical Trials 52

Clinical Trials Trials Production Compliance 52

Agency IQ

AUGUST 18, 2023

A deep dive into MDR and IVDR implementation: Where we are and where we’re going Late last summer, AgencyIQ took a close look at how the European Commission had been meeting its goals in implementing the medical device and IVD regulations (MDR and IVDR, respectively). regulators. reference laboratories. reference laboratories.

Science 40

Science Regulations Laboratories Production 40

Drug Target Review

SEPTEMBER 19, 2023

This major shift to the orthodox tradition of using animal experiments in drug testing dates back the Aristotle’s time and cemented 80 years ago with initial federal mandate of drug safety regulation of 1938. Nature Cancer. 2022;3(4):418-36. Passini E, Britton OJ, Lu HR, Rohrbacher J, Hermans AN, Gallacher DJ, et al.

Animal Testing 98

Animal Testing Clinical Trials Pharmaceutical Companies FDA 98

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 ).

Trials 52

Trials Vaccine FDA Biosimilars 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 Government Drug Trials 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 132

Vaccine Trials Disease Virus 132

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 Animal Testing Engineering 52