Original Post For Immediate Release: September 14, 2022 Today, the U.S. Food and Drug Administration and the National Institutes of Health (NIH) announced the launch of the Critical Path for Rare Neurodegenerative Diseases (CP-RND) – a public-private partnership aimed at advancing the understanding of neurodegenerative diseases and fostering the development of treatments for amyotrophic lateral…
Read MoreOriginal Post Summary Company Announcement Date: September 06, 2022 FDA Publish Date: September 06, 2022 Product Type: Medical Devices Reason for Announcement: Potential risk of serious injury Company Name: Royal Philips’ subsidiary Philips Respironics Brand Name: Philips Product Description: Certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps Company Announcement These…
Read MoreOriginal Post For Immediate Release: September 07, 2022 Today, the U.S. Food and Drug Administration is announcing steps to further increase monkeypox testing capacity and accessibility nationwide as part of its continued commitment to addressing the ongoing outbreak. “Since the beginning of the monkeypox outbreak, the agency has used the full breadth of its authorities…
Read MoreOriginal Post September 6, 2022 Audience Parents and caregivers of infants who consume infant formula Product Product: Mother’s Touch Formula Distribution: The product is sold at local markets in Kinzers, Loganton, and Gap, PA and was available for purchase directly from Mother’s Touch website. Product Images Purpose The FDA advises parents and caregivers not to buy or…
Read MoreOriginal Post For Immediate Release: August 31, 2022 Today, the U.S. Food and Drug Administration approved Xenpozyme (Olipudase alfa) for intravenous infusion in pediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD), a rare genetic disease that causes premature death. Xenpozyme is the first approved medication to treat symptoms that are not related to the…
Read MoreOriginal Post The virus that causes COVID-19 changes over time. Keep your protection up to date by getting an updated COVID-19 vaccine booster. The updated COVID-19 vaccine boosters include components of the original virus strain and the Omicron variant. This is called a bivalent COVID-19 vaccine. The updated COVID-19 vaccine boosters are designed to give…
Read Morehttps://www.dea.gov/press-releases/2022/08/30/dea-warns-brightly-colored-fentanyl-used-target-young-americans
Read MoreOriginal Post By: Robert M. Califf, M.D., Commissioner of Food and Drugs In 2021, a record number of Americans – more than 107,000 – died from drug overdoses. While the loss of human life alone is staggering, we know that the effects of the drug overdose crisis are even broader, including enormous individual and societal costs as people and…
Read MoreCertain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication
Original Post Date Issued: August 29, 2022 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. If that plastic is…
Read MoreOriginal Post Summary Company Announcement Date: August 22, 2022 FDA Publish Date: August 22, 2022 Product Type: Drugs Reason for Announcement: Potential presence of visible particulate Company Name: Hospira, Inc., a Pfizer Company Brand Name: Hospira Product Description: Propofol Injection Emulsion, USP Company Announcement FOR IMMEDIATE RELEASE -NEW YORK, NY., August 22, 2022 Hospira, Inc.,…
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