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CMS Issues Proposed Guidance on Part D Coverage Gap Discount
…prospective payments to each Part D plan to the actual amount of discounts to each of the plan’s enrollees, which CMS will calculate based on the discount amounts reported in…
Breakthrough Designation Guidance Finalized
…plan for a new Safer Technologies Program (STeP), originally outlined in April 2018 as part of the Medical Device Safety Action Plan. While additional details are forthcoming in 2019, Gottlieb…
GAO Finds Continued Need for FDA Drug Postmarket Safety Oversight Improvement; Seeks Timeline for Transfer of Certain Protocol Reviews from OND to OSE
…calls Equal Voice, intended to ensure the equal participation of all relevant parties. OSE and OND signed a Memorandum of Understanding in June 2008 that states the agency’s intent for…
What to Do When You Receive a DEA Order to Show Cause
…of service of the Order to Show Cause. A third option is to ignore the Order to Show Cause, in which case DEA will request a final order based only…
The ACA Contraceptive Mandate (Part 2)
…the ACA, a 2019 HRSA Guideline, and guidance from the federal agencies responsible for enforcing the contraceptive coverage requirement of the ACA (the Departments), women seeking contraceptives that were not…
Are You Talking? Because CDRH Says It’s Listening (At Least If You Are In the Digital Health Space): Notes from A Two Day Workshop
…and effective digital health products. One step in the plan is developing a Digital Health Software Precertification (Pre-Cert) Program. We blogged on the overall digital health plan here. As part…
Clinical Trials Join the Remote Work Revolution: FDA’s New Draft Guidance on Decentralized Clinical Trials
…can also potentially be conducted by local health care providers close to a participant’s home, rather than clinical trial personnel. DCTs often include the use of digital health technologies (DHTs),…
FDA Commissioner Gottlieb Emerges as a Champion for Patient Engagement in 2018; Patient-Centric Guidance Development, Rare Disease Listening Sessions, and the Benefit-Risk Framework
…engagement policies and aiding patient communities engaging in medical product development and regulatory decision-making, it is refreshing to see the Nation’s top drug official further elevate progress in this area,…
And Then There Were Seven: FDA Issues the Final Rule on Intentional Adulteration of Food; the Last Required by FSMA
…food that may result in large-scale public harm. The final rule specifically exempts several categories of facilities: Facilities that have less than 10 million dollars in annual sales, during a…
Farm Bill Creates Legal Framework for Hemp, But Challenges Remain
…substance, and any product derived from the plant or parts of the plant is also not controlled. By the same token, a Cannabis plant and any part of a Cannabis…
FDA on Gene-Edited Plants and Animals: “We’ve Got This”
…regulatory framework, see here). Although additional guidance on regulation of plant biotechnology products is under development, the thrust of the Action Plan appears geared toward animal biotechnology products – a…
Designer Anabolic Steroid Control Act of 2012 Introduced; Would Bulk Up Federal Anabolic Steroid Controls
…would also require anabolic steroids and products containing anabolic steroids to bear a label identifying such contents. Lastly, the Act would also subject violators to specific civil and/or criminal penalties…
REMS Program Violations Result in Disgorgement and False Claims Act Liability
…approved, FDA required a REMS to mitigate the potential risk in humans of a rare form of cancer called Medullary Thyroid Carcinoma (MTC). According to the Complaint, between 2010 and…
Generic Drug Trade Association Sues to Enjoin Maryland Price Gouging Law
…$80. HB 631 also arms the AG with civil remedies for violations of the above provisions, including injunctive and monetary relief as well as civil penalties. AAM’s complaint challenges HB…
Proposed Changes to the Device Intended Use Regulation
…putative governmental interest in bringing additional uses on label. One court has expressly found in a First Amendment context that FDA has a legitimate governmental interest in bringing all additional…