FDA Update GDUFA Enforcements Announced for the Next Five-Year Period The Generic Drug User Fee Amendments (GDUFA) was originally enacted in 2012 as part of the Food and Drug Administration Safety and Innovation Act and was authorized for a period of 5 years.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
FDA update RE: FDA Announces the Availability of a Proposed Rule: Revising the National Drug Code Format and Drug On July 22, 2022, FDA announced the availability of a proposed rule to adopt a single, uniform 12-digit format (a universal 6-4-2 format) for FDA-assigned NDCs. In addition, the FDA proposes to revise the label requirements
FDA Update PATIENT LABELING for HUMAN Rx and Biological Products Patients and Caregivers Alike Can Finally Rely on Clear Usage Instructions for Prescription and Biological Drugs as the FDA Issues Final Guidance on Instructions for Use Documents The U.S. Food and Drug Administration has issued a final guidance, “Instructions for Use – Patient Labeling for
FDA Update “Put Down the Wand” FDA Warns Against the Use of Certain Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation Periodically what seems like a good idea goes awry. During the pandemic everyone was looking to keep all surfaces including hands disinfected. One method of disinfecting surfaces was the use of a
FDA Update According to the FDA a Permanent Solution to the Baby Formula Supply Chain Shortage is On the Way A baby formula problem caused by the FDA is that same FDA that is now trying to fix it. As usual, our REACTIVE government came up short in anticipating a problem and did not offer
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