On August 5, 2024, FDA’s Center for Devices and Radiological Health (CDRH) published a discussion paper entitled, “Discussion Paper: Health Equity For Medical Devices” (Discussion Paper), to aid in its efforts to advance...more
In the CY 2024 Physician Fee Schedule Proposed Rule (the Proposed Rule), the Centers for Medicare & Medicaid Services (CMS) proposed a further delay in implementing its time-only definition for determining the “substantive...more
The latest efforts by the U.S. Food and Drug Administration (FDA) to modernize regulation of the 510(k) program come in the form of a trio of new draft guidance documents regarding its Premarket Notification program for...more
Biologics have long been defined by their processes, raising complicated questions about how to assess the effect of manufacturing changes on product quality—i.e., whether pre- and post-change products are comparable. This...more
Idaho’s new Virtual Care Access Act (the “Act”) amends Idaho’s existing law to make it easier to render telehealth in Idaho effective July 1, 2023. The requirements of the new Act are summarized below....more
On March 15, 2023, the U.S. Food and Drug Administration (“FDA”) issued updated draft guidance, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations–Questions and Answers (“Draft...more
In a September 2022 filing in U.S. ex rel. Osinek v. Kaiser Permanente, the Kaiser Permanente consortium defendants (Kaiser) highlighted the distinction between clinically inaccurate diagnoses (factual falsity) and clinically...more
Part 1 of this article discussed the background and purpose of the EU In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR), the definition of in vitro diagnostic medical devices (IVDs), the risk-based classification system,...more
You want to make sure you are prepared if your case is headed toward a custody psychological evaluation. A psychological evaluation in a custody case can occur for a number of reasons, including issues associated with drug or...more
After having dealt with the issue when software may be considered a medical device according to its intended purpose (in part 2) and the implications of the new risk classification regime (in part 3), in this part 4 of our...more
For those not familiar with the term, a “meta-analysis” is a quantitative, formal, epidemiological study design used to systematically assess the results of previous research to derive conclusions about that body of research....more
This week, FDA Commissioner Stephen M. Hahn, M.D., along with Dr. Anthony S. Fauci, M.D., of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, and officials from the Centers for...more
A federal court in Rhode Island allowed a former employee to proceed with her lawsuit alleging that the employer violated state law when it terminated her employment after a positive breath alcohol test. Stafford v. CSL...more
Late last week, the U.S. Food and Drug Administration (FDA) announced it approved the use of spun synthetic swabs similar to Q-tips for use in testing for COVID-19....more
WHAT HAPPENED: • Recent developments indicate that pharmaceutical deals are attracting greater scrutiny from the Federal Trade Commission (FTC). • In September 2019, FTC Chairman Joseph Simons reportedly stated that the...more
On 27 September 2019 the U.S. Food and Drug Administration (FDA or the agency) released the draft guidance entitled "Clinical Decision Support Software" (CDS guidance), which updates the framework for FDA's oversight of CDS...more
Dealing with clinical studies can be one of the more challenging aspects of being an advertising/marketing lawyer, particularly if you are one of many lawyers who took the political science/econ route to law school. ...more
Federal Court finds invalidity allegations relating to patent for metformin formulations not justified - On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of...more
On March 4, 2019, the final Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information) and Regulations Amending the Medical Devices Regulations (Public Release of Clinical Information)...more
On 4 October 2018, the European Parliament adopted its Report on the Commission Proposal for a Regulation on Health Technology Assessment (HTA)....more
Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more
On 22 September 2017, the European Medicines Agency (“EMA”) published an external guidance document concerning the implementation of Policy 0070 on the publication of clinical data for medicinal products for human use....more
Earlier this week, the FDA made gene therapy available for the first time in the United States. This decision, ushers in “a new approach to the treatment of cancer and other serious and life-threatening diseases” said the...more
Following their adoption by the European Parliament in April 2017, the final versions of the Medical Devices Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR") were published in the Official Journal of the...more
The U.S. Food and Drug Administration announced the availability of a draft guidance for the clinical evaluation of software as a medical device (SaMD). The draft guidance was prepared by the SaMD Working Group of the...more