FDA News

HOUSTON--(BUSINESS WIRE)--IntuiTap Medical, a medical device company focused on improving the accuracy and efficiency of lumbar punctures and intrathecal drug delivery, announced the appointment of Ric Cote as Executive Chairman of the Board. Mr. Cote brings decades of leadership experience in the medical device industry, with a track record spanning company building, commercialization, strategic growth, and successful exits. Most recently, he served as Chief Executive Officer and a member of t...

EVANSTON, Ill.--(BUSINESS WIRE)--Flashpoint Therapeutics, a biotechnology company pioneering a new class of structural nanomedicines, today announced the appointment of Venkat R. Krishnamurthy, Ph.D., as Chief Scientific Officer. Dr. Krishnamurthy is an accomplished scientific and executive leader with more than 15 years of experience developing RNA therapeutics, bringing deep expertise in oligonucleotide chemistry, drug delivery, and advancing genetic medicine programs from discovery through c...

DUBLIN--(BUSINESS WIRE)--The "Understanding Medical Device Regulatory Pathways - 510(k), PMA & Exemptions (January 15, 2026)" training has been added to ResearchAndMarkets.com's offering. This expert-led 3-hour webinar provides a comprehensive introduction to the key regulatory pathways for medical device submissions in the US market. The regulation and control of new or substantially changed medical devices for sale in the US is based on the 510(k), PMA or DeNovo submission process. This w...

DUBLIN--(BUSINESS WIRE)--The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems Course (Jan 22nd - Jan 23rd, 2026)" training has been added to ResearchAndMarkets.com's offering. What are U.S. FDA CGMP expectations/requirements for Post Market Surveillance and Complaint Handling? This seminar will examine Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as appropriate articles / Annexes of the EU's MDR, which require manu...

DUBLIN--(BUSINESS WIRE)--The "Peptide Therapeutics Market: Industry Trends and Global Forecasts, Till 2040 - Distribution by Type of Peptide, Route of Administration, Key Therapeutic Area and Geographical Regions" has been added to ResearchAndMarkets.com's offering. The peptide therapeutics market is poised for significant growth, projected to escalate from USD 84.2 billion in 2023 to USD 162.4 billion by 2035, marking a CAGR of 6.8%. These therapeutics, built from polypeptides, are increasingl...

PLYMOUTH, Minn.--(BUSINESS WIRE)--VizMark Secures FDA 510k clearance for VM1 Visual Tumor Marker, Advancing Precision in Breast Cancer Imaging...

DUBLIN--(BUSINESS WIRE)--The "Auditing and Qualifying Suppliers and Vendors: An Effective Risk-based Approach (Mar 3rd - Mar 5th, 2026)" training has been added to ResearchAndMarkets.com's offering. Supplier or vendor qualification is a crucial component in compliance to 21 CFR 111. The FDA requires that manufacturers of dietary supplements, Pharmaceuticals, Biotech and Medical Device must "qualify" each of their vendors but do not provide guidance on how a company is to perform this qualificat...

DUBLIN--(BUSINESS WIRE)--The "Regulatory Compliance for Dietary Supplements in the US, EU and Canada (Jan 15th - Jan 16th, 2026)" training has been added to ResearchAndMarkets.com's offering. A nutraceutical product with quality as good as a pharmaceutical drug is possible when you apply the required GMP norms. Technological feasibility, safety, and cost efficiency are a few things to take into consideration when applying these GMP principles. This dietary supplement formulation training covers...

WESTBOROUGH, Mass.--(BUSINESS WIRE)--Miach Orthopaedics' BEAR Implant label updated to include significantly lower risk of post-traumatic osteoarthritis following ACL injury....

HYDERABAD, India & PRINCETON, N.J.--(BUSINESS WIRE)--Dr. Reddy’s launched Olopatadine Hydrochloride Ophthalmic Solution USP 0.7% (OTC), a generic equivalent of Extra-Strength Pataday® Once Daily Relief....