Saturday, August 24, 2019

Saturday, August 24, 2019

Latest News

FDA policymaker to keynote hemp business summit

Leading authorities on hemp are set to gather next week in Portland, Oregon, in anticipation of learning more about upcoming regulations to the industry.

FDA Update: Mammography Procedure Numbers

Mammograms per year in the nation numbered more than 39.5 million as of Aug. 1, the U.S. Food and Drug Administration reports.

NETFLEX: NextFlex’s Technology Hub Complies With FDA Standards for Manufacturing of Medical Devices

Adherence to FDA Quality Standards Will Boost Ability of Fabrication Facility to Produce Pilot-Scale Devices for NextFlex Members and Customers

FDA issued 14 warning letters to companies in July

The U.S. Food and Drug Administration issued 14 warning letters in July that were sent to manufacturers and other companies found to have violated FDA regulations.

FDA releases final PMSR requirements for combination drugs

The Food and Drug Administration (FDA) recently released guidelines for safety reporting for combination products that clarify which companies and products must abide by the final rules on post-marketing safety reporting (PMSR) requirements and how exactly to do so.

MESA BIOTECH INC.: Mesa Biotech to Present Comparative Flu & RSV Detection Analysis with Other FDA-Cleared Molecular Assays at the AACC Annual Scientific Meeting Lecture Series

Mesa Biotech Inc. is a privately-held, molecular diagnostic company that has developed the Accula™ System, an affordable, sample-to-answer, CLIA-waived PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis

Republican senators introduce innovation-driven drug-treatment bill; brace for resistance from FDA

Two Republican senators recently introduced a bill they claim would combat U.S. drug shortages and drive down the prices of drugs and medical devices by allowing patients to select treatments approved in other countries.

FDA issued 34 warning letters to companies in June

The U.S. Food and Drug Administration issued 34 warning letters in June that were sent to manufacturers and other companies found to have violated FDA regulations.

WUXI APPTEC: WuXi STA Shanghai & Changzhou Facilities Pass U.S. FDA Inspections

STA Pharmaceutical Co., Ltd., (WuXi STA) – a subsidiary of WuXi AppTec – announces that its Analytical Service Unit (ASU) in Shanghai and active pharmaceutical ingredient (API) process R&D and manufacturing facility in Changzhou, have successfully passed two inspections from the U.S. Food and Drug Administration (FDA) within the same week, with no Form 483s issued.

AVA president says parents should play of a role in banning sales of vape products to minors

The American Vaping Association says FDA fear-mongering on vaping products for minors could end up making the products more enticing.

U.S. FOOD AND DRUG ADMINISTRATION: FDA suspends facility registration of Texas-based seafood producer after significant, repeated food safety violations

The U.S. Food and Drug Administration announced it has recently suspended the food facility registration of Topway Enterprises Inc., also doing business as Kazy’s Gourmet, of Houston, Texas. Topway now cannot sell or distribute any food into commerce.

U.S. FOOD AND DRUG ADMINISTRATION: Federal judge enters consent decree against Arkansas food and medical product grocery warehouse for insanitary conditions

The U.S. District Court for the Western District of Arkansas ordered J and L Grocery, LLC. of Alma, Arkansas, the company’s owner, James T. White, and its manager, Lori A. Layne, to stop distributing food, drug products, medical devices and cosmetics until the company complies with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in a consent decree.

Annual volume of FDA-regulated imported goods up 5-10%

Products imported into the United States that require screening by the Food and Drug Administration continue to increase at a rate between 5 and 10 percent annually, the FDA reports.

NEOVASC, INC.: Neovasc to Explore HDE Approval Pathway and Alternate Trial Designs for the Reducer Following Guidance from the FDA

Neovasc Inc. ("Neovasc" or the "Company") (NASDAQ: NVCN)(TSX: NVCN), a leader in the development of minimally invasive transcatheter mitral valve replacement technologies and in the development of minimally invasive devices for the treatment of refractory angina, announced that the Food and Drug Administration ("FDA") has provided guidance to the Company following its Sprint Discussion on June 26, 2019, together with the Company's consultants and supporting U.S. cardiologists to review the clinical evidence collected to date for the Neovasc Reducer™ (the "Reducer"), to determine the most expedient pathway to potentially gaining regulatory approval in the United States and the quickest path to the U.S. market for these patients with an unmet need.

Doctor says FDA should do more to combat opioid crisis

The Food and Drug Administration unveiled yet another draft guidance on opioid addiction, but one doctor remains unimpressed.

FDA Reporter