Advarra

MARCH 21, 2023

Regulations for research involving devices, in vitro diagnostics (IVDs), and digital therapeutics differ from those governing pharmaceutical development. The greater the risk, the more likely a series of trials for market clearance or approval will be required. In other words, what are the risks and benefits of the product?

Clinical Trials 52

Clinical Trials Clinical Trials Trials Production 52

pharmaphorum

SEPTEMBER 29, 2022

Part 2 of this series will be devoted to clinical decision support (CDS) software. The FDA has opined on several categories of mHealth: general wellness devices, mobile medical applications (MMAs), and clinical decision support (CDS) software. The FDA’s General Approach to Regulating mHealth Products. not a medical device, ii.

Development 96

Development Regulation Production Life Science 96

Drug Discovery World

DECEMBER 8, 2023

With human clinical trials with AI-designed drugs now ongoing, it’s only a matter of time until the FDA approves its first AI-designed drug. With human clinical trials with AI-designed drugs now ongoing, it’s only a matter of time until the FDA approves its first AI-designed drug.

Gene Therapy 64

Gene Therapy Gene In-Vitro Development 64

Pharmaceutical Technology

NOVEMBER 22, 2022

The mission was first put forward during the UK’s G7 Presidency of June 2021, with support from representatives of the life sciences industry. Vaccines are our number one weapon in the fight against infectious diseases, but their development has historically involved a long and complex process taking up to a decade.

Manufacturing 130

Manufacturing Vaccination Vaccine RNA 130

pharmaphorum

OCTOBER 4, 2022

Part 2 of this series is devoted to clinical decision support (CDS) software. peer-reviewed clinical studies and clinical practice guidelines) (Criterion 2); (3) intended for the purpose of supporting or providing recommendations to an HPC about prevention, diagnosis, or treatment of a disease or condition (Criterion 3); and. (4)

Development 101

Development Regulation Cosmetics Life Science 101

XTalks

JUNE 12, 2023

Medtronic’s proactive stance towards R&D is evident from the over 230 clinical trials it conducted and the more than 200 regulatory approvals it received in the US, Europe, Japan and China in the 2022 fiscal year. Note: When it comes to companies that report in foreign currencies, the conversion to U.S.

FDA Approval 98

FDA Approval Production Sales In-Vitro 98