FDA Update Not All Drugs Products Are Created Equally – PLEASE REVIEW THIS FDA publishes draft guidance for industry: Sameness Evaluations in an ANDA – Active Ingredients On November 8, 2022, FDA published a new draft guidance for industry entitled “Sameness Evaluations in an ANDA – Active Ingredients.”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
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
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
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
FDA Update GDUFA Enforcements Announced for the Next Five-Year Period The Generic Drug User Fee Amendments (GDUFA) was originally enacted in 2012 as part of the Food and Drug Administration Safety and Innovation Act and was authorized for a period of 5 years.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
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.,
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
FDA Inspections: How to Respond to a Request for an Affidavit By Alan P. Schwartz, Senior Partner, mdi Consultants Dealing with the FDA during an inspection could cause real emotional stress to say the least. Should you respect the request of FDA investigator if you are not sure what the consequences would be at a
FDA Encourages the Development of Generic Drugs As They Publish Product-Specific Guidances FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, helping to streamline generic product development and ANDA assessment. FDA publishes PSGs to help
FDA Update Just Announced… NEW FEES FY2023 User Fee Rates for the Voluntary Qualified Importer Program (VQIP) and the Accredited Third-Party Certification Program (TPP) The U.S. Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2023 user fee rates for importers approved to participate in the Voluntary Qualified Importer Program (VQIP), and accreditation
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