FDA Announces FY2020 Voluntary Qualified Importer Program (VQIP) Fee Rates – The FDA made the fee rates for FY2020 available for the Voluntary Qualified Importer Program and Third-Party Certification Program. The rates were effective July 24, 2019.
FDA Issues Authorization of Soy Leghemoglobin as a Color Additive – The FDA announced that it would be “amending the color additive regulations to provide for the safe use of soy leghemoglobin as a color additive in ground beef analogue products (e.g., ‘veggie’ burgers).”
FDA Releases Q&A on Nonclinical Toxicology Studies – The FDA published a draft guidance titled “Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers.” The draft addresses “the management and conduct of pathology peer review performed during good laboratory practice (GLP)-compliant toxicology studies.”
FDA Issues a Draft Guidance on Neonatal Studies – The FDA made a guidance available titled “General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Guidance for Industry.” The guidance is intended to supplement “the FDA draft guidance titled General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products (December 2014), as it addresses general clinical pharmacology considerations in neonates, a pediatric subpopulation.”
FDA Publishes Guidance on Clinical Studies – The FDA released a draft guidance titled “E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES.” The draft “focuses on designing quality into clinical studies, considering the diversity of clinical study designs and data sources used to support regulatory and other health policy decisions.”
FDA Gives Guidance on Oncology Therapeutic Radiopharmaceuticals – The FDA issued a final guidance titled “Oncology Therapeutic Radiopharmaceuticals: Nonclinical Studies and Labeling Recommendations Guidance for Industry.” The guidance intends to “provide information to assist sponsors in the design of an appropriate nonclinical program for the development of radiopharmaceuticals to treat cancer – also known as oncology therapeutic radiopharmaceuticals – and to provide recommendations for certain aspects of product labeling.”
FDA Releases Guidance on Medical Devices in the Magnetic Resonance (MR) Environment – The draft guidance, titled “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment,” provides “recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling.”
FDA Seeks Comments on Proposed List of Harmful Constituents – The FDA has asked for public comment on 19 proposed additions to the tobacco harmful and potentially harmful constituents (HPHCs) list. Public comments must be made prior to Oct. 4, 2019.
HHS Announces Drug Importation Action Plan – HHS made its “Safe Importation Action Plan” available. The plan outlines two pathways for the safe importation of drugs not intended for the U.S. market. One pathway is to support “pilot (or demonstration) projects developed by states, wholesalers or pharmacists and submitted for HHS review, outlining how they would import certain drugs from Canada that are versions of FDA-approved drugs that are manufactured consistent with the FDA approval.” The other would be to allow drug manufacturers of FDA-approved drugs to import certain versions of those drugs they sell in other countries.