Pace® Life Sciences Announces Successful Outcomes Following US FDA Inspection of Operations in San German, Puerto Rico
Pace® Life Sciences, LLC, a full-service FDA-registered central laboratory and contract development and manufacturing organization (CDMO), announced the receipt of an overall positive review from...
CorDx Receives Emergency Use Authorization (EUA) for 10-Min Flu A/B & COVID-19 Test
FDA Grants CorDx Emergency Use Authorization for Multi-Target Rapid Test for Flu A/B & COVID-19 CorDx, a global leader in the development, manufacturing, and distribution...
Amid FDA Concerns, HTL-Strefa Inc. Offers a Reliable and Safe Alternative to Chinese Supplied Needles & Syringes With European-Produced Sicura™ Passive Safety Needle
DropSafe® Sicura™ is the first and only fully passive safety needle in North America. Sicura™ designed to eliminate needlestick injuries, providing a safe injection experience, and...
Amid FDA Concerns of Chinese Supplied Needles & Syringes, HTL-Strefa Inc. Offers a Reliable and Safe Alternative With Its European-Produced Passive Safety Needle, Sicura TM
DropSafe® Sicura™ is the first and only fully passive safety needle in North America. Sicura™ is designed to eliminate needlestick injuries, providing a safe injection experience,...
Statement by Fragrance Creators Association on Funding to Support Implementation of the Modernization of Cosmetics Regulation Act
Fragrance Creators Association (FCA) and CEO Farah K. Ahmed issue the following statement on funding to support the Food and Drug Administration’s (FDA) implementation of...
Advocacy Groups Join Reagan-Udall Foundation and FDA for Workshop on Developing Biomarkers to Support Accelerated Approval in Rare Diseases
Workshop Presented Overwhelming Scientific Evidence to Support CSF-HS as a Primary Biomarker in Neuropathic MPS Disorders On February 21, 2024, Cure Sanfilippo Foundation, National MPS...
Droice Labs Discusses SuperLineage for Real-World Data Traceability at FDA Listening Session
Droice Labs met with the Food and Drug Administration’s Real-World Evidence Subcommittee in a listening session held on Feb. 2, 2024. The topic of this...
ASTCT Supports the FDA’s Accelerated Approval of AMTAGVI for Treatment of Metastatic Melanoma
The American Society for Transplantation and Cellular Therapy® (ASTCT®) supports the decision by the US Food and Drug Administration’s (FDA) to grant accelerated approval to...
CorDx is Expected to Launch Groundbreaking 10-Minute Solution for Distinguishing COVID-19 and Flu A/B as Respiratory Cases Surge Across the U.S.
Against the backdrop of a concerning surge in respiratory diseases leading to widespread alarm across the United States, CorDx has submitted its application for its CorDx TyFast...
ZetrOZ Systems’ sam 2.0 Wearable Ultrasound Unit Receives New FDA Clearance for Expanded Medical Indications
Agency’s decision signifies that ZetrOZ’s sustained acoustic medicine technology is safe and effective for promoting injury healing in wider range of medical conditions. The sam®...