On November 16, 2020, the Food & Drug Administration (FDA) issued guidance entitled, Electromagnetic Compatibility of Medical Devices. FDA has developed this guidance document to describe relevant information that should be provided in a premarket submission (i.e., premarket approval application (PMA), humanitarian device exemption (HDE), premarket notification (510(k)) submission, investigational device exemption (IDE), and De Novo request) to support a claim of electromagnetic compatibility for electrically powered medical devices and medical devices with electrical or electronic functions. This draft guidance is not intended to change current policy, but to provide specific technical information to address the recommendations originally described in the guidance entitled “Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices” published July 11, 2016 (2016 EMC guidance). This draft guidance is not final nor is it in effect at this time.
On November 17, 2020, FDA issued guidance entitled, Product-Specific Guidance for Tiotropium Bromide. This draft guidance, when finalized, will provide product-specific recommendations on, among other things, the information and data needed to demonstrate bioequivalence (BE) to support abbreviated new drug applications (ANDAs) for tiotropium bromide inhalation spray.
On November 18, 2020, FDA issued a notice of availability for several product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of BE studies to support ANDAs.
On November 19, 2020, FDA issued guidance entitled, Cross Labeling Oncology Drugs in Combination Drug Regimens. This guidance describes FDA’s current recommendations on including relevant information in labeling for oncology drugs approved for use in combination drug regimens.
On November 19, 2020, FDA issued guidance entitled, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the Biologics Price Competition and Innovation Act of 2009. The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilars and proposed interchangeable biosimilars, as well as to describe FDA’s interpretation of certain statutory requirements added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This draft guidance document provides new Q&As. It does not replace the draft guidance document entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2),” issued December 12, 2018.
On November 20, 2020, FDA issued guidance entitled, Clinical Drug Interaction Studies With Combined Oral Contraceptives. This guidance assists sponsors of investigational new drug applications and new drug applications in evaluating the need for and design drug-drug interaction (DDI) studies involving combined oral contraceptives (COCs) during drug development as well as determining how to communicate the results and recommendations from the DDI studies. Specifically, this guidance focuses on the conduct of clinical studies to evaluate the DDI potential of an investigational drug on a COC, including the need for and design of the clinical studies and the interpretation of the study results.
On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule with comment period (IFC) entitled, Most Favored Nation Model. This IFC implements the Most Favored Nation (MFN) Model, a new Medicare payment model under section 1115A of the Social Security Act (the Act). The MFN Model will test whether more closely aligning payment for Medicare Part B drugs and biologicals (hereafter, referred to as “drugs”) with international prices and removing incentives to use higher-cost drugs can control unsustainable growth in Medicare Part B spending without adversely affecting quality of care for beneficiaries.
On November 20, 2020, the Department of Health and Human Services (HHS) issued a final rule entitled, Fraud And Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals And Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees. Discounts for prescription pharmaceutical products are central to this final rule, in which the HHS amends the safe harbor regulation concerning discounts. Amending this regulation changes the definition of certain conduct that is protected from liability under the Federal anti-kickback statute of the Social Security Act. New regulatory text in the amendment revises the discount safe harbor. By excluding from the definition of a discount eligible for safe harbor protection certain reductions in price or other remuneration from a manufacturer of prescription pharmaceutical products to plan sponsors under Medicare Part D or pharmacy benefit managers (PBMs) under contract with them, HHS modifies the existing discount safe harbor in particular contexts. Existing safe harbors otherwise remain unchanged. Safe harbors are also created for two additional types of arrangements. The first protects certain point-of-sale reductions in price on prescription pharmaceutical products, and the second protects certain PBM service fees.
On November 20, 2020, CMS issued a final rule entitled, Modernizing and Clarifying the Physician Self-Referral Regulations. This final rule addresses any undue regulatory impact and burden of the physician self-referral law. This final rule is being issued in conjunction with the CMS Patients over Paperwork initiative and the HHS Regulatory Sprint to Coordinated Care. This final rule establishes exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. It also establishes a new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician; establishes a new exception for donations of cybersecurity technology and related services; and amends the existing exception for electronic health records (EHR) items and services. This final rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations.
On November 20, 2020, HHS issued a final rule entitled, Fraud and Abuse; Revisions to Safe Harbors under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements. This final rule amends the safe harbors to the Federal anti-kickback statute by adding new safe harbors and modifying existing safe harbors that protect certain payment practices and business arrangements from sanctions under the anti-kickback statute. This rule is issued in conjunction with the HHS Regulatory Sprint to Coordinated Care and focuses on care coordination and value-based care. This rule also amends the civil monetary penalty (CMP) rules by codifying a revision to the definition of “remuneration” added by the Bipartisan Budget Act of 2018.
With an Engineers degree in Advanced Database Management and Information Security, Sandesh brings the deep understanding of the digital world to the table. His articles reflect the challenges and the complexities that come along with every disruption in the industry. He carries over six years of experience on working with websites and ensuring that the right article reaches the right reader.