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No Password Required: A Senior Product Manager at GitLab With an Instagram Alter Ego That Puts Her in Privacy Superhero Territory
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More CBD Certainty: Clearing Confusion over Hemp in New York State
Lowndes Client Corner Podcast Episode 5 - Winter Park Distilling Company Brews One-Of-A-Kind Facility in Winter Park
Podcast: Non-binding Guidance: FDA’s Regulation of Products Containing CBD
Polsinelli Podcasts - The Latest on a Shift in Regulation in Dietary Supplements
PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
On August 29, 2024, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued an untitled letter to AbbVie, Inc. (AbbVie) regarding a promotional, direct-to-consumer (DTC) television...more
The U.S. Food and Drug Administration (FDA) has issued a Safety Communication advising healthcare providers to stop implanting Equinoxe Shoulder System joint replacement devices manufactured by Exactech. The Safety...more
In an August 8 press release, the US Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) announced that it does not intend to renew its longstanding memorandum of understanding (MOU) with the Association...more
LEGISLATION, REGULATIONS & STANDARDS - Vermont Governor Signs Law Banning PFAS from Cosmetics - Vermont Gov. Phil Scott has signed into law a bill banning several chemicals including per- and polyfluoroalkyl...more
On July 17, 2024—but just recently posted to the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) website—FDA issued its second untitled letter (letter) of the year to Kaleo, Inc....more
On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more
In 1990, Congress enacted the Nutrition Labeling and Education Act (NELA) as an amendment to the Food, Drug and Cosmetic Act (FDCA). Among other things, NELA 1) provided for modernization and standardization of the familiar...more
Reliably Determining Reasonable Royalty Rates from Lump Sum Licenses - In Ecofactor, Inc. V. Google LLC, Appeal No. 23-1101, The Federal Circuit held that license agreements containing a lump sum payment “based on” a royalty...more
Dietary supplement industry leaders and regulators gathered in Salt Lake City in June to examine the current status of the Dietary Supplement Health and Education Act of 1994 (DSHEA), 30 years after that legal building block...more
Before Moore, Lourie, and Albright. Appeal from the United States District Court for the District of Delaware. Summary: The totality of the complaint’s allegations must be considered when assessing whether induced patent...more
The Federal Circuit reversed a decision from the District of Delaware dismissing a case for failing to plead induced infringement because the totality of the evidence raised fact questions that could not be resolved on a...more
Last November, the U.S. Patent and Trademark Office issued Guidance to the Examiner Corps that was disclosed to the public at the March 19, 2024 Biotechnology, Chemical, and Pharmaceutical Partnership Meeting, on resources to...more
Device manufacturers may soon have access to a new framework for marketing and selling medical devices in the United Kingdom. On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published...more
Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more
FDA recently issued a revised draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products. This...more
On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more
On April 25, 2024, FDA published a revised draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products –...more
ACI and CRN are excited to welcome you back to New York City this Spring for our 12th Legal, Regulatory & Compliance Forum on Dietary Supplements. Network and collaborate with over 150 industry stakeholders to explore how...more
Hosted by American Conference Institute, the Summit on Biosimilars & Innovator Biologics returns to New York City, on June 20 - 21, 2024. Now in its 15th year, the 2024 conference will dive deep into the latest legal,...more
On April 3, 2024, FDA published Draft Guidance titled New Dietary Ingredient Notification Master Files for Dietary Supplements (the Draft Guidance). The Draft Guidance provides recommendations on how stakeholders can...more
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
On March 5, 2024, the US Food & Drug Administration (FDA) released final guidance titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” The guidance is meant to...more
Several recent cases arising under the federal Food, Drug, and Cosmetic Act (“FDCA” or the “Act”), 21 U.S.C. § 301 et seq., highlight the usefulness of preemption as a defense against putative class actions concerning drugs,...more
Most years are eventful for businesses regulated by the US Food and Drug Administration (“FDA”), and 2023 was no exception. 2024 promises more of the same – it being a Presidential election year, some FDA decisions (increased...more
On February 22, 2024, the Federal Communications Commission (FCC or “Commission”) released a Public Draft of a Report and Order that, if adopted, would establish a voluntary labeling program for Internet of Things (IoT)...more