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Software as a Medical Device: Challenges Facing the Industry

Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians and other organizations...more

DEA Extends Telemedicine Flexibilities for Prescribing of Controlled Medications

On May 10, 2023, the Drug Enforcement Agency (DEA) released a new regulation – “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” – temporarily extending the “full set” of...more

FDA’s New Guidance Proposes Flexible Use of AI in Medical Devices

On April 3, 2023, U.S. Food and Drug Administration (FDA) issued its much anticipated draft guidance, "Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning...more

The Laws of Fashion: What's Trending in 2023

The fashion industry has experienced another year of continued change driven by consumer trends, innovation in technology, geopolitical and public health issues, and legal developments, and we don’t anticipate that stopping...more

COVID-19 Related Medical Devices: FDA Finalizes Transition Plan Guidance

On March 27, 2023, the U.S. Food & Drug Administration (FDA) released two final guidance documents to assist with transitioning medical devices: (i) that were subject to certain enforcement policies issued during the COVID-19...more

Foley & Lardner Comment Letter on DEA Telemedicine Controlled Substance Proposed Rule

On March 1, 2023, the Drug Enforcement Agency (DEA) officially published proposed rules for prescribing controlled substances via telemedicine after the COVID-19 Public Health Emergency expires. The DEA gave the public a 30...more

Modernization of Cosmetics Regulation Act of 2022: What You Need to Know

On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act, 2023, which includes the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA significantly changes the current regulatory...more

Wondering if Your Digital Health Product or Service is Subject to FDA Regulations?

The convergence of wearable technology and artificial intelligence systems that can analyze data in real time to optimize health care delivery is generating a new wave of products that raise novel regulatory, business, and...more

Supply Chain Shortages in the Meat and Poultry Industries

With Thanksgiving fast approaching, you have probably heard that there is a turkey shortage – brought about by a combination of rising costs for feed and fuel, continued labor shortages, and – if that were not enough –a...more

Hearing Aids: More Accessible to Consumers After FDA Issues Final Rule

Many people experience hearing loss and related hearing issues. To date, to get a hearing aid, people needed a prescription and to see a licensed hearing aid specialist in order to be properly diagnosed and fitted for a...more

FDA Allows Pharmacists to Prescribe the COVID-19 Antiviral Paxlovid

On July 6, the U.S. Food and Drug Administration (FDA) revised its emergency use authorization (EUA) for the COVID-19 antiviral treatment PaxlovidTM (nirmatrelvir and ritonavir) to allow prescribing by pharmacists for quicker...more

Cannabis Mid-Year Update 2022

Well into the third year of the global pandemic, with record inflation and the uncertain outcomes of geopolitical issues roiling global markets, the cannabis industry has nevertheless continued upon a similar path as recent...more

Snackable: Food & Beverage Review

We invite you to enjoy a review of the food and beverage industry with bite size articles ranging from regulatory and real estate trends to litigation and M&A happenings. The past two years have seen significant changes...more

Mexican Authorities Remove Foodstuff Products Due to NOM 051 Labeling Requirements Non-Compliance

The Mexican Federal Commission for the Protection Against Sanitary Risks (Cofepris) and the Federal Consumer Prosecutor's Office (Profeco) removed more than 10,000 units of domestic and imported foodstuff products that were...more

The Laws of Fashion: What's Trending in 2022

The fashion industry has certainly seen its fair share of change over the last year given consumer trends, geopolitical & public health issues, innovation in technology and legal developments and we don’t anticipate that...more

FDA Drafts Public Health Emergency Transition Plan: What Device Manufacturers Need to Know

The U.S. Food & Drug Administration (FDA) previously issued emergency use authorizations (EUA) and adopted emergency policies in response to the COVID-19 public health emergency (PHE) to facilitate the availability of key...more

COVID-19 Lab Tests: HHS Withdraws Policy Limiting FDA’s Review, and FDA Issues an Updated Policy Requiring EUAs

On November 15, 2021, the U.S. Department of Health and Human Services (HHS) announced the withdrawal of the policy established during the previous administration that limited U.S. Food and Drug Administration’s (FDA) ability...more

Get Real: Preventing Counterfeit Product with Blockchain

The counterfeit business is booming. In fact, counterfeit goods account for a whopping 3.3% of global trade and cost the U.S. economy approximately $600 billion a year. The Dangers of Counterfeit Products - Counterfeiting...more

California OEHHA Proposes New Safe Harbor Warnings for Acrylamide in Foods

On September 17, 2021, the California Office of Environmental Health Hazard Assessment (“OEHHA”) proposed new, alternative safe harbor warnings for acrylamide exposures in food. OEHHA’s stated goal is to reduce the potential...more

The Fast Track: Using Blockchain to Trace Products Through the Supply Chain

Many companies need strong supply chain traceability. For the most prevalent tracing challenges, blockchain may provide a formidable solution. Real-World Applications - Using blockchain to trace products is especially...more

Latest Open Payments Data Released Under Heightened Government Scrutiny

On June 30, 2021, the Centers for Medicare & Medicaid (CMS) released Open Payments data for the past year, 2020. This new data publication comes amid heightened government scrutiny of payments by drug and medical device...more

Food & Beverage Supply Chain Desk Reference

Foley & Lardner’s Food & Beverage Industry Team has authored a new handbook entitled, “Food & Beverage Supply Chain Desk Reference.” For the sake of convenience, the Desk Reference includes quick answers to your legal needs...more

Round Two - FDA Issues Emergency Use Authorization for Moderna’s COVID-19 Vaccine

What You Need to Know: On December 18, 2020, the Food and Drug Administration issued the second emergency use authorization (“EUA”) for a vaccine for the prevention of COVID-19 in individuals 18 years of age and older. Under...more

FDA Issues Emergency Use Authorization for Pfizer-BioNTech COVID-19 Vaccine

What You Need to Know: Late on December 11, 2020, the Food and Drug Administration issued the first emergency use authorization (“EUA”) for a vaccine for the prevention of COVID-19 in individuals 16 years of age and older....more

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