FDA Update FDA Proposes Requirements for How Requestors Can Make Minor Dosage Form Changes to Certain Over-the-counter Monograph Drugs The U.S. Food and Drug Administration (FDA) is proposing requirements for how requestors can make minor dosage form changes to certain over-the-counter (OTC) monograph drugs. FDA issued Proposed Administrative Order OTC000038 that, if finalized, will specify
FDA Update – January 17, 2025 FDA Releases Draft Guidance on Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency The FDA has issued a new draft guidance to help developers validate diagnostic tests (IVDs) for emerging pathogens during public health emergencies. This guidance aims to ensure that
FDA Update For In Vitro Diagnostic Test Developers: Updates to the FDA’s Clinical Laboratory Improvement Amendments (CLIA) Web Pages Make Processes Clearer, Easier to Understand The Clinical Laboratory Improvement Amendments (CLIA) and the associated regulations provide the authority for oversight of clinical laboratories and laboratory testing. While the Centers for Medicare and Medicaid Services (CMS)
FDA Update It took awhile but we saw this coming – the EUAs will be ending. Further Guidance Clarification Post COVID Just Announced by FDA Enforcement Policy for Face Masks, Barrier Face Coverings, Face Shields, Surgical Masks, and Respirators Today, the U.S. Food and Drug Administration (FDA) divided into two the guidance, Enforcement Policy for
Further Protection Against Counterfeit, Stolen, Contaminated, or Otherwise Harmful Drugs is On the Way FDA is announcing the availability of two guidances to help trading partners comply with the Drug Supply Chain Security Act (DSCSA). These documents are critical steps toward implementing the DSCSA enhanced drug distribution security requirements that will go into effect on
Is the Safety of Our Food Supply Compromised? FOR YOUR INFORMATION The FDA Wants to Know as They Issue Warnings to Four Companies for Illegally Selling CBD Products Intended for Use in Food-Producing Animals The U.S. Food and Drug Administration (FDA) has issued warning letters to four companies illegally selling unapproved animal drugs containing cannabidiol
FDA Proposes Changes to Agricultural Water Requirements in the Produce Safety Rule In an effort to address and eradicate potential contamination in regard to pre-harvest agricultural water the U.S. Food and Drug Administration published a proposed rule that would revise subpart E of the FDA Food Safety Modernization Act (FSMA) Produce Safety Rule to change certain pre-harvest
No Surprise – Effective October 1, 2021 FDA User Fees Will Increase These fees will be effective through September 30, 2022. Fortunately, the increases will not be too large for FY2022. The FDA annual registration fee for each establishment is $5,672 (in United States dollars) up from the $5546 of 2021. As previously, there are
This past week, Costco Wholesale Corporation became the first approved participant in the FSMA Voluntary Qualified Importer Program (VQIP). This program is a voluntary, fee-based program that allows importers to receive expedited review and importation of human and animal foods into the United States under the FSMA. Costco has shown management of safety and security
Possible Major Changes to 510(k) Program A 510(k) premarket submission is the most commonly used pathway to obtain an FDA market clearance for new medical devices. The essence of the 510(k) process is a demonstration of substantial equivalence (that is a device to be marketed is at least as safe and effective as a legally marketed
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