Tag: regulatory affairs

Phase 1 Human Abuse Liability Studies – BioPharma Services

Clinical TrialsOctober 2, 2023

The Importance of Clinical Trials Well-designed clinical trials pave the way for knowledge and access to new treatments and procedures that can benefit millions around...

Navigating the Regulatory Maze: How PSC Biotech Lights the Way

BiotechnologySeptember 25, 2023

Regulatory affairs (RA) is a profession in the life science industry that involves checking whether a...

How pharmaceutical manufacturers can guarantee a seamless eIFU implementation

Medical DevicesSeptember 22, 2023

Implementing an eIFU-platform is a significant undertaking. But the potential benefits more than making up for this;...

765 Air Travel – Airplane Geeks Podcast

AviationSeptember 13, 2023

Podcast: Play in new window | Download (Duration: 1:22:01 — 37.6MB) We look at the state of air travel, and the outlook for the future....

The Vital Role of Embedded Sites in Community Engagement | Alcanza Clinical Research

Clinical TrialsSeptember 11, 2023

Embedded sites play a critical role in expanding research into communities, particularly among traditionally underrepresented groups in clinical trials. Lora Parahovnik, PhD, President and...

Commercialization of regenerative-medicine therapies – Nature Reviews Bioengineering

BiotechnologySeptember 3, 2023

Oberweis, C. V., Marchal, J. A., López-Ruiz, E. & Gálvez-Martín, P. A worldwide overview of regulatory frameworks for tissue-based products. Tissue Eng. B 26,...

Memo to Congress: Fix the Farm Bill | Project CBD

CannabisAugust 23, 2023

Earlier this year, the Food & Drug Administration disclosed that it would not regulate non-pharmaceutical CBD products, thereby putting the onus on Congress to...

Oncology Drugs Trials in Healthy Volunteers – BioPharma Services

Clinical TrialsAugust 21, 2023

The DIA 2023 Annual Meeting in Boston gathered experts, professionals, and regulators from around the world...

9 Ways Worldwide’s Partnership Approach Fits Your Biotech Growth Journey

Clinical TrialsAugust 15, 2023

August 15, 2023 Selecting the right CRO to partner with on your development program is a pivotal decision that can shape...

MCRA Aids Surmodics in Obtaining FDA Pre-Market Approval for Cardiovascular Drug-Coated Balloon | BioSpace

Medical DevicesAugust 6, 2023

WASHINGTON, Aug. 7, 2023 /PRNewswire/ -- MCRA, LLC, a leading medical device focused regulatory advisory firm and clinical research organization (CRO) integrating...

BREATHE! Convention Expected to Connect Emerging Tech Communities While Making History in Las Vegas, Nevada on September 13-15, 2023 – CryptoCurrencyWire

BlockchainAugust 3, 2023

The Web3, AI, Blockchain, Cryptocurrency, DeFi, Metaverse, and NFT communities will come together September 13-15th, at The Expo @ World Market Center Las Vegas...