FDA: Provides Guidance to Industry for Detecting and Preventing Nitrosamines in Drugs
The following is attributed to FDA Commissioner Stephen M. Hahn, M.D., and Patrizia Cavazzoni, M.D., acting director, Center for Drug Evaluation and Research
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FDA: Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests
The U.S. Food and Drug Administration published comparative performance data for some authorized COVID-19 molecular diagnostic tests.
FDA: Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products
We proposed updates to our regulations to clarify the types of evidence the FDA considers when determining the “intended use” of a product.
FDA: Achieves Key Milestone, Finalizes Framework That Will Resume Shellfish Trade with Europe for the First Time in 10 Years
U.S. Food and Drug Administration finalized a molluscan shellfish equivalence determination for two European Union (EU) Member States, Spain and the Netherlands.
CAPSOVISION INC.: Announces FDA Enforcement Discretion for At-Home Capsule Endoscopy Administration of CapsoCam Plus during COVID-19
CapsoVision, an innovator in the gastroenterology diagnostics market, announced that the U.S Food & Drug Administration (FDA) will apply enforcement discretion which allows at-home administration of the CapsoCam Plus® small bowel capsule endoscope during the COVID-19 pandemic for patients who are determined eligible for at-home administration.
AKERO THERAPEUTICS: To Continue Efruxifermin Development With Innovative Adaptive Phase 2b/3 Clinical Trial Design Based On FDA Written Guidance
Therapeutics, Inc. (Nasdaq: AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, today announced that written guidance from the U.S. Food and Drug Administration (FDA) enables the company to implement an innovative combined Phase 2b/3 study design for pivotal efruxifermin (EFX) trials in NASH patients.
GENSCRIPT PROBIO: Congratulates XLifeSc on FDA Allowance of IND Application for TCR-T Program
On September 24, XiangXue Life Sciences (XLifeSc), a partner of GenScript ProBio, announces FDA allowance of its IND application for TCR-T program (TCRT-ESO-A2). GenScript ProBio extends congratulations on this.
CONSUMERS FOR DENTAL CHOICE: Consumer, medical, environmental, parent groups praise FDA recommendations against amalgam for children, pregnant women, and other vulnerable populations
Consumers for Dental Choice issued the following announcement on September 24.A broad array of consumer, medical, parents, and environmental groups are lauding a new safety communication from the U.S.
NEUROPHTH THERAPEUTICS: Treatment of Leber's Hereditary Optic Neuropathy Gene Therapy NR082 was Granted Orphan Drug Designation by U.S. FDA
Neurophth Therapeutics, Inc., (hereinafter referred to as "Neurophth") today announced that its leading candidate, NR082 (rAAV2-ND4, NFS-01 project), was granted an orphan drug designation (ODD) by the U.S. FDA for the treatment of Leber's Hereditary Optic Neuropathy associated with ND4 mutation.
BAUSCH HEALTH COMPANIES INC.: FDA Approves Bausch + Lomb Alaway® Preservative Free (Ketotifen Fumarate) Ophthalmic Solution, 0.035%
First OTC Preservative-Free Eye Drop Approved for the Treatment of Itchy Eyes Associated with Allergies. Provides Up to 12 Hours of Eye Itch Relief
BIOVICA: Completes 510(k) submission for DiviTum®TKa to the FDA
Biovica, active in blood-based cancer diagnostics, today announced that the company has filed a 510(k) submission with the U.S. Food and Drug Administration (FDA).
REMEGEN: Announces US FDA Has Granted Breakthrough Therapy Designation for Disitamab Vedotin (RC48) in Urothelial Cancer
The Breakthrough Therapy designation marks an important milestone for RemeGen's leading ADC treatment for urothelial cancer