FDA Newsfeed

… Administration premarket approval — the FDA process of review to evaluate … cybersecurity draft guidance, the FDA has decided to issue a … Until July 7, the FDA is inviting medical device manufacturers … for medical devices. While FDA guidance is nonbinding, the …

… production restarts. The FDA has eased import restrictions … products in February after FDA inspectors found Cronobacter … ; Califf told lawmakers. FDA inspectors found shocking conditions … inspection. Though the FDA received the whistleblower complaint …

… compound CMND-100. “The FDA's interest in CMND … is aiming to initiate FDA-regulated clinical trials with … IND meeting package to the FDA in April, which included … (IND) application. Responses from FDA representatives were constructive and supportive …

… ;20220525006058/en/ “The FDA's clearance reflects our … stone and urine medium.” The FDA cleared Revolix™ HTL, LISA Laser …

… .S. Food and Drug Administration (FDA) announced 510(k) clearance (pre … are very pleased to receive FDA 510(k) clearance with a …

… US Food and Drug Administration (FDA) has granted approval for Servier …

… .com. Back to Healio The FDA approved ivosidenib tablets in combination … metastatic IDH1-mutated cholangiocarcinoma. The FDA based the approval of the …

FDA officials appeared before a congressional … are also questions surrounding the FDA's investigation and response … former Abbott employee whistleblower. Related: FDA Allows Import Of 2M Baby …

… and Drug Administration's (FDA) black box warning of increased …

… to severe nationwide shortages. FDA leaders appeared before a … surrounding the timeline of FDA's investigation and … mail routing issues, FDA officials said. "FDA's … more optimal," acknowledged FDA Commissioner Robert Califf. …

… amp; Drug Administration (FDA). In October 2021, the FDA had delayed to … was deemed inappropriate by the FDA. FDA has asked the company to … The company noted that the FDA confirmed, based on the … a court determines that FDA erred in requesting a certification …

By Chris Wack Perrigo Co. Plc shares were up 2%, to $39.94, after the company said it has received final approval from the U.S. Food and Drug Administration for omeprazole magnesium delayed-release mini capsules, 20 mg over-the-counter. The company expects …

… Nov. 30, 2022. Additionally, the FDA indicated that the agency is … Officer, said, "With the FDA's acceptance of our … launch in early 2023. The FDA grants Priority Review that shortens …

… improvement in liver fibrosis. The FDA's decision is supported … Fast Track designation from the FDA reinforces Pfizer's belief …

… Abbott products sparked the recent FDA investigation. An inspection, … Nutrition CEO acknowledged an FDA investigation "did discover … issues raised by the FDA." Subsequently, Abbott … no additional comment. The FDA provided previously published press …

… " conditions, the FDA said.  FDA commissioner Robert Califf said … Food and Drug Administration.  FDA commissioner Robert Califf said … bacteria, cronobacter sakazakii. The FDA could not link the … internal issues within the FDA that delayed an investigation …

By Chris Wack Apyx Medical Corp. said it has received 510(k) clearance from the U.S. Food and Drug Administration for the use of the Renuvion Dermal Handpiece for specific dermal resurfacing procedures. The Renuvion Dermal Handpiece is indicated for …

… and commercialize cilta-cel. The FDA has accepted Reata Pharmaceuticals Inc … in the U.S. The FDA has granted Fast Track designation …

… .S. Food and Drug Administration (“FDA”) for the use of the … are very pleased to receive FDA 510(k) clearance with a … ; the impact of the recent FDA Safety Communication on our business …

… . Food and Drug Administration ("FDA") for the use of … are very pleased to receive FDA 510(k) clearance with a … ; the impact of the recent FDA Safety Communication on our business …

… Fast Track designation from the FDA reinforces Pfizer's belief …

… US Food and Drug Administration (FDA) for a molecular SARS-CoV … patent-pending and U.S. FDA Class I exempt RHINOstic Automated … devices with the U.S. FDA and may be used for …

… Understanding Use of Excel and FDA Audit Preparation" training … in compliance with the FDA regulations for analytical equipment … instruction on preparing for FDA audits and becoming part … #47;or respond to FDA inspectional observations and warning …

… US Food and Drug Administration (FDA).  Niclosamide is the active ingredient … the Animal Rule from the FDA.  The Animal Rule is a … of CP-COV03 to the FDA quickly. Scientists at Kansas State … treatment for monkeypox with the FDA’s fast-track designation, we …