Drugs And Medical Devices Group

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Drug Manufacturers & Distributors | Texas DSHS

https://www.dshs.texas.gov/drug-manufacturers-distributors

The Drugs and Medical Devices Unit ensures drug manufacturers and distributors comply with minimum licensing standards to protect the health and safety of Texans. We inspect prescription and over-the-counter (OTC) drug manufacturers and distributors to make sure they meet these standards. When voluntary compliance with the licensing standards cannot be achieved, we recommend regulatory actions.

Inside Clinical Trials: Testing Medical Products in People

https://www.fda.gov/drugs/information-consumers-and-patients-drugs/inside-clinical-trials-testing-medical-products-people

The FDA has authority over clinical trials for drug, biologic, and medical device products regulated by the agency.

Importing Medical Devices | FDA

https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices

Registration and listing. Establishments that are involved in the production and distribution of …

When is a drug a device? - Pharmaceutical Technology

https://www.pharmaceutical-technology.com/features/drug-device-fda-regulation/

Drugs vs devices: the regulatory process Within the FDA, the Center for Drug Evaluation and Research handles the regulation of drugs, while the Center for …

New MDCG 2022-5 Guidance on Borderline between Devices …

https://namsa.com/new-mdcg-2022-5-guidance-borderline-between-devices-drugs-mdr/

In late April 2022, the long-awaited Medical Device Coordination Group (MDCG) guidance on borderline devices under the Medical Device Regulation (MDR) …

2023 Drugs and Medical Devices FDA and EMA Updates

https://www.linkedin.com/pulse/2023-drugs-medical-devices-fda-ema-updates-raouf-hajji-md-phd-

The 23rd Newsletter of Healthcare Present & Future will focus on the Drugs and the Devices approved by U.S Food and Drugs Agency (FDA) and European …

ProPharma Group Launches Revolutionary New Operating Model …

https://finance.yahoo.com/news/propharma-group-launches-revolutionary-operating-120000348.html

RALEIGH, N.C., Jan. 9, 2023 /PRNewswire-PRWeb/ -- ProPharma Group – the end-to-end, global provider of regulatory, clinical and compliance services for the …

Drug and Drive Advisory Group

https://www.drugdeviceadvisory.com/

Drug and Drive Advisory Group We are a consulting group for Clinical Pharmacology and Regulatory Strategy for Drugs and Medical Devices. Our interest is in assisting Small …

Medical Device Coordination Group Working Groups - Public Health

https://health.ec.europa.eu/medical-devices-dialogue-between-interested-parties/medical-device-coordination-group-working-groups_en

Medical Device Coordination Group Working Groups. The Medical Device Coordination Group (MDCG) deals with key issues from the medical devices sector, from Notified …