FDA Publishes Guidance on Nutrition and Supplement Facts Labels – The FDA “prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28). This guidance document restates in plain language the revisions made in the final rule and is intended to help small entities comply with the requirements established in 21 CFR 101.9, 101.30, and 101.36.”
FDA Opens VQIP Application Portal – The Voluntary Qualified Importer Program (VQIP) is a voluntary fee-based program that “provides expedited review and importation of human and animal foods into the United States for participating importers who achieve and maintain a high level of control over the safety and security of their supply chains. The portal will remain open until May 31, 2020.”
FDA Releases Database with Human Immunodeficiency Virus (HIV) Drug Information – The mobile-friendly database “offer[s] a wealth of critical information about antiretrovirals (ARVs) eligible for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR) program. This launch is an important step in our ongoing commitment to address the global HIV epidemic and is consistent with our efforts to modernize and improve access to information and unleash the power of data.”
FDA Approves First Peanut Allergy Treatment – The drug, which is indicated for individuals from 4 to 17 years old, is “to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts.”
FDA and FTC Announce Steps to Support Biologics Competition – The agencies released a joint statement focused on enhancing “collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products. This joint statement describes key steps the agencies will take to address false or misleading promotion about biosimilars within their respective authorities and deter anti-competitive behavior in this space.”
FDA Publishes Guidance on Reducing the Risk of Creutzfeldt-Jakob Disease Transmission – The draft guidance is intended to provide “blood establishments that collect blood and blood components with revised recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components.”
FDA Releases Cardiovascular Outcome Claims Guidance – The guidance was issued to help applicants “developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. With few exceptions, current labeling for antihypertensive drugs includes only the information that these drugs are indicated to reduce blood pressure; the labeling does not include information on the clinical benefits related to cardiovascular outcomes expected from such blood pressure reduction.”
FDA Issues Biologics and Biosimilar Guidance – The guidance, titled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers,” “addresses questions firms may have when developing FDA-regulated promotional labeling and advertisements (promotional materials), for prescription reference products licensed under 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)).”
FDA Publishes 2020 Guidance Priorities – In the document, the FDA outlines its new and revised draft guidance document related to drugs for 2020.
FDA Revises Generic Drug Application Prioritization Policy – The FDA released a revision to the Manual of Policies and Procedures (MAPP) 5240.3, Prioritization of the Review of Original ANDAs, Amendments, and Supplements. The FDA stated, “This update aims to efficiently allocate limited agency resources to areas where priority review is most likely to meaningfully increase generic drug access and ensure fairness to applicants.”
FDA Announces Emergency Use Authorization for Coronavirus Test – The FDA granted an emergency use authorization to allow the Centers for Disease Control and Prevention (CDC) to use a coronavirus diagnostic panel. The FDA stated, “[T]his test has been limited to use at CDC laboratories; today’s authorization allows the use of the test at any CDC-qualified lab across the country.”
FDA Publishes Guidance on Arthroscopy Pump Tubing Sets – The guidance outlines “recommendations for 510(k) submissions for arthroscopy pump tubing sets intended for multiple patient use. These devices are designed to deliver irrigation fluid to the surgical site, such as knee, shoulder, hip, elbow, ankle, and wrist joint cavities, during arthroscopic procedures.”
FDA Warns Maker of Nicotine-Containing Toothpick – The FDA warned a company selling dissolvable tobacco products, citing a number of alleged violations, including “selling a tobacco product to a minor through the company’s website; selling unauthorized modified risk tobacco products; and failing to include required nicotine warning statements on both packaging and advertising.”
Michigan Governor Signs Remote Pharmacy Bill – Senate Bill 340 outlines the requirements to allow remote pharmacies to operate in the state of Michigan.
Trump Administration Announces Healthy Adult Opportunity (HAO) – HAO is an initiative “designed to give states unprecedented tools to design innovative health coverage programs tailored to the unique needs of adult beneficiaries, while holding states accountable for results and maintaining strong protections for our most at-risk populations.”
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