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News and Info

06 Feb

FDA Update: FDA Announces Funding Opportunity to Support Pediatric Medical Device Development

FDA Update Spotlight on Children as FDA Announces Funding Opportunity to Support Pediatric Medical Device Development The U.S. Food and Drug Administration (FDA) announced a funding opportunity through the Pediatric Device Consortia (PDC) grants program open through Wednesday, March 29, 2023, 11:59 p.m. (ET). The FDA funds this program to advance the development of medical

12 Dec

FDA Food Safety Program

A new report on the FDA’s food safety program just came out.  One of the recommendations is to break up the Agency into 2:  one for food and another for medicine. – READ ON Protecting the nation’s food supply is one of FDA’s primary charges.  While affirming that Americans generally have access to safe and

Food Traceability
22 Nov

Food Traceability Under FSMA

FDA Update Foodborne Illnesses May Soon Be Fewer and Far Between As… FDA Announces the Final Rule for Food Traceability Under FSMA The U.S. Food and Drug Administration (FDA) issued a final rule on food traceability designed to facilitate faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or

ANDA
14 Nov

ANDA

FDA Update Not All Drugs Products Are Created Equally – PLEASE REVIEW THIS FDA publishes draft guidance for industry: Sameness Evaluations in an ANDA – Active Ingredients On November 8, 2022, FDA published a new draft guidance for industry entitled “Sameness Evaluations in an ANDA – Active Ingredients.” The guidance is intended to assist applicants

11 Nov

MAUDE

FDA Update FDA Updates Fields Available in the Manufacturer and User Facility Device Experience (MAUDE) Database and open FDA This new rules for the MDR reporting requirements. It will now include the UDI number. The U.S. Food and Drug Administration (FDA) updated its public adverse event databases to include fields for the Unique Device Identifier

08 Nov

Infant Head Shaping Pillows

FDA Update FDA Warns of a Risk of Suffocation and Death Infant Head Shaping Pillows Should Never Be Used to Prevent or Treat Any Medical Condition The U.S. Food and Drug Administration (FDA) recommends that parents and caregivers do not use infant head shaping pillows intended to change an infant’s head shape or symmetry or

04 Nov

Medical Device Shortages

FDA Update As the Medical Device Shortage List Grows, the FDA Alerts Patients and Health Care Providers of Alternatives and Temporary Strategies Here are two recent reportable shortages of medical equipment. (1)        REUSE TRACHEOSTOMY TUBES OR SWITCH TO APPROPRIATE ALTERNATIVES DURING SHORTAGE – FDA SAFETY COMMUNICATION The U.S. Food and Drug Administration (FDA) is

06 Oct

GDUFA Enforcement

FDA Update GDUFA Enforcements Announced for the Next Five-Year Period The Generic Drug User Fee Amendments (GDUFA) was originally enacted in 2012 as part of the Food and Drug Administration Safety and Innovation Act and was authorized for a period of 5 years. This allows the FDA to assess and collect user fees to help

Human and Animal Food Facilities
03 Oct

Human and Animal Food Facilities

FDA Update It is registration time again reminds the FDA… Human and Animal Food Facilities to Register or Renew Registration between October 1 and December 31, 2022 Owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the U.S.,

Covid-19 tests
28 Sep

FDA Updates COVID-19 Test Policy

As the COVID-19 Crisis Settles Begins to Settle into a More “Endemic” State, FDA Updates COVID-19 Test Policy, Encourages Developers to Seek Traditional Premarket Review for Most Test Types We were expecting this change – here it is. The U.S. Food and Drug Administration updated its COVID-19 test policy to ensure continued access to tests

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