National Law Review11h
Telehealth Companies and Social Media Influencers May Face New FDA Laws
Whether or not telehealth companies are under FDA jurisdiction when marketing and promoting prescription drugs has been under ...
USFDA Inspection On The Rise Over Indian Medtech Industry
I3CGlobal FDA INSPECTION BANGALORE, INDIA, March 14, 2025 /EINPresswire / -- Indian pharmaceutical, nutraceutical, and medical devic ...
The BMJ5d
Late adverse event reporting from medical device manufacturers to the US Food and Drug Administration: cross sectional study
Objective To describe the extent of late adverse event reporting by manufacturers to the US Food and Drug Administration’s (FDA) Manufacturer And User Facility Device Experience (MAUDE) database as ...
ValGenesis VLMS Chosen to Simplify Validation Complexity for Major U.S. Healthcare Provider
ValGenesis Inc., the market leader in enterprise validation lifecycle management systems (VLMS), announced today that a major ...
National Law Review8d
FDA Issues FSVP-Related Warning Letters
Both warnings letters were issued after multiple inspections and following failures to respond to FDA 483a forms issued at ...
Federal Register15d
Administrative practice and procedure
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug ...
The Globe and Mail18d
Shares Of AI Company Surging On FDA 510(k) Clearance News
Shares of Ventripoint are surging on the news that the company had received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for their VMS+™ 4.0 Automated Radiological Image ...
Khaleej Times19d
UAE: New drug saves 21-year-old with rare disease who once 'struggled to get out of bed'
For the last four years, 21-year-old Muhammad ... an innovative treatment designed for AIP patients. The drug is administered as an injection every month. The medication works by reducing toxic ...
Finanznachrichten20d
Celularity Inc.: Celularity Receives FDA Tissue Reference Group Recommendation Letters for its Natalin and Acelagraft Wound Care Products
in response to the Company's requests regarding its Natalin and Acelagraft products confirming that each product "appears to meet all the criteria for regulation solely under section 361 of the PHS ...
TipRanks on MSN20d
Celularity receives FDA TRG recommendation letters for Natalin, Acelagraft
Celularity (CELU) received recommendation letters from the US Food and Drug Administration, or FDA, Tissue Reference Group, or TRG, in response to ...