DE Under 3: Big Changes Coming to OFCCP's Supply & Service Contractor ICRs
As announced earlier this month, the longstanding Memorandum of Understanding (MOU) between the Food and Drug Administration (FDA or Agency) and the Association of American Feed Controls Officials (AAFCO) will expire on...more
The United States Patent and Trademark Office (USPTO) released a Notice on the Federal Register (“the Notice”) today requesting public commentary and input on the current state of the experimental use exception. The USPTO is...more
The U.S. Department of Agriculture (USDA) and U.S. Patent and Trademark Office (USPTO) have recently opened requests for stakeholder engagement regarding biotechnology regulatory frameworks. These requests provide the...more
The listing of many types of patents in the FDA’s Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is fairly straightforward. Patents covering the approved drug product (active pharmaceutical...more
During its first meeting of the year, scheduled for March 22-23, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) will review a Government Accountability Office (GAO) report that faulted both the Food...more
On February 23, 2023, the U.S. Patent and Trademark Office (USPTO) held a virtual panel discussion on the duty of disclosure and duty of reasonable inquiry. While both duties apply regardless of technology area, the...more
The U.S. Food and Drug Administration (FDA) published a final rule creating additional recordkeeping requirements for foods listed on the Food Traceability List. The final rule was published in the Federal Register on...more
The Guidance published in the Federal Register last April for “veterinarians, State-licensed pharmacies, and Federal facilities” regarding compounding animal pharmaceuticals will take effect April 2023. The guidance focuses...more
The Medical Marijuana and Cannabidiol Research Expansion Act (MMCREA) became law last Friday. The bipartisan legislation will roll back federal restrictions on medical marijuana research and the cultivation of research-grade...more
On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more
The U.S. Food and Drug Administration (FDA) released a statement on May 31, 2022, that its Center for Devices and Radiological Health (CDRH) will once again be accepting all pre-submissions for all in vitro diagnostic (IVD)...more
On March 2, 2022, FDA hosted a public Device Good Manufacturing Practice Advisory Committee meeting, where the Committee discussed the proposed rule titled "Medical Devices: Quality System Regulation Amendments."...more
The U.S. Food and Drug Administration (FDA) issued the much-anticipated proposed rule “Medical Devices: Quality System Regulation Amendments,” which will harmonize the current Quality System Regulation (QSR; 21 CFR Part 820)...more
The Federal Circuit has recently provided substantial guidance on whether printed publications include documents publicly available via the internet. This article reviews four such cases that illustrate the expansive view...more
On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) announced that it is rescinding the Medicare Coverage of Innovative Technology and Definition of “Reasonable and Necessary” (MCIT/R&N) final rule,...more
As critical product shortages arose during the early days of the COVID-19 pandemic, the Food and Drug Administration (FDA) issued guidance documents outlining temporary policies that allowed non-drug manufacturers to produce...more
Premarket Notification Again Required for Patient and Surgeon's Examination Gloves and Dozens of Class II Devices Proposed for Exemption by Former HHS Secretary - On April 16, 2021, the Food and Drug Administration (“FDA”...more
On December 29, 2020, the U.S. Food and Drug Administration (FDA) announced in a Federal Register notice the 2021 fee schedule for its Over-the-Counter Monograph Drug User Fee Program. That user fee program was an addition...more
On November 20, 2020, the United States Department of Health and Human Services (HHS) issued a Federal Register notice to: (1) withdraw the Food and Drug Administration’s (FDA) Compliance Policy Guide (CPG) Sec. 440.100...more
In an effort to both promote innovation against COVID-19 and promote dissemination of information about innovation against COVID-19, the USPTO is launching a new “deferred fee” pilot program for certain provisional patent...more
Time Is Ripe To Update SOPs And To Ensure Compliance with Results Submission Requirements - In recent days, the federal Department of Health and Human Services (“HHS”) clarified the requirements for submission of certain...more
Small business efforts to patent technology which deals with the COVID-19 outbreak will be getting a boost thanks to the United States Patent and Trademark Office (USPTO)...more
The U.S. Food and Drug Administration (FDA) recently issued a Federal Register notice (the notice) that the FDA intends to conduct a web-based survey for a "more current understanding of the prevalence of adverse reactions to...more
On Tuesday, the Food and Drug Administration (FDA or the agency) published a draft guidance document, "Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements,"...more
In Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, the Federal Circuit affirmed decisions of the Patent Trial and Appeal Board (PTAB) that invalidated seven Orange Book-listed patents for Xyrem®. The main issue on...more