FDA Reclassification Updates Earlier this week, the FDA issued a final order which reclassified several families of medical devices. These devices include certain radiological medical image analyzer such as Computer-Assisted Detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection devices. These devices have been reclassified from
FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs The FDA issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving over-the-counter (OTC) drugs produced by foreign manufacturers found to have serious violations of federal law. The warning letter outlines multiple cGMP regulation violations at
FDA Will Continue Enforcement Discretion Policy Relevant to Certain Co-Manufacturers under FSMA. The FDA will be continuing its enforcement discretion policy for compliance with certain FDA Food Safety Modernization Act (FSMA) supply-chain program requirements applicable to receiving facilities that are co-manufacturers. “Co-manufacturing” is when one party (the brand owner) arranges for a second party (the
FDA Announces Cooperative Agreement to Implement Produce Safety Rule The U.S. Food and Drug Administration (FDA) announced a cooperative agreement with the National Association of State Departments of Agriculture (NASDA) that was established to help carry out the produce safety rule as part of the FDA’s ongoing efforts to implement the FDA Food Safety Modernization
Federal judge enters consent against Tennessee drug, dietary supplement and device distributors, Basic Reset and Biogenyx for drug, device, and dietary supplement violations. A federal judge in Tennessee ordered a consent decree of permanent injunctions against two Tennessee-based companies, Basic Reset and Biogenyx. The permanent injunction prohibits the two companies and their owners from distributing
Notice of intent to inactivate outdated drug listing records. The FDA has announced its intention to begin inactivating drug listing records that are not properly listed in accordance with FDA requirements because these drug listings are not certified as being active and up to date; or are associated with a manufacturing establishment that is not
FDA announces the user fee rates for prescription drugs, generic drugs, biosimilars, and outsourcing facilities for FY 2020 As part of the FDA, CDER also known as the Center for Drug Evaluation and Research regulates new drugs including prescription and generic drugs, before they can be sold. The FDA is authorized to collect application fees
FDA announces the MDUFA fees for FY 2020. The FDA announced its fee rates and payments procedures for medical device user fees for the FY 2020. Fee rates for FY 2020 were adjusted for inflation. The fee rates go into effect from October 1, 2019 to September 30, 2020.The application fee should be paid for
CDRH appeals processes and provides guidance pertaining to FDA significant decisions. The Center for Devices and Radiological Health (CDRH) issued an updated guidance document describing the processes available for individuals outside of the FDA to request a review of the decisions made by the CDRH on which they disagree with. Such processes that are recommended
FDA releases a proposed rule on biologics license applications and master files The FDA issued a proposed rule to amend its regulations relating to the use of master files for biological products. As per the requirements of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), marketing applications for biological products that previously could
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