On October 3, 2023, the U.S. Food and Drug Administration (FDA) published a proposed rule to regulate laboratory-developed tests (LDTs). The rule, if finalized, would amend FDA regulations to broaden the definition of “in...more
The U.S. Food and Drug Administration (FDA) is making efforts to modernize both the 510(k) approval process for medical devices and study designs for drugs and biologics....more
In late September 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on “Regulatory Considerations for Prescription Drug Use-Related Software.” This guidance expands on (and was developed in response...more
In November 2021, the Centers for Medicare & Medicaid Services (CMS) rescinded a short-lived program to expedite national Medicare coverage for innovative devices amid safety concerns for Medicare patients. CMS has strived...more
The U.S. Food and Drug Administration (FDA) is continuing its effort to provide industries with updated guidance for digital health technologies. On April 3, 2023, the FDA released draft guidance titled “Marketing Submission...more
The medical product and healthcare service industry is one of the most closely regulated sectors in the U.S. Several agencies actively exercise authority with constantly changing legislation and policies to keep pace with...more
2/13/2023
/ False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
Medicare ,
Pharmaceutical Industry ,
Private Equity ,
Telemedicine
On January 30, 2023, the Biden administration announced its intent to end the national emergency and public health emergency (PHE) declarations on May 11, 2023. These emergency declarations have been in place since early...more
Host Mary O'Brien interviews Wilson Sonsini partner Paul Gadiock exploring the convergence of the gaming and healthcare industries....more
Businesses making health claims about their products (e.g., foods and dietary supplements) or services (e.g., apps) should take note of new guidance that the Federal Trade Commission (FTC) released at the end of December...more
Wilson Sonsini is pleased to present the latest edition of The Life Sciences Report. This issue features an article on interlocking boards in the life sciences sector and the antitrust risk they pose to firms and investors;...more
The U.S. Food and Drug Administration (FDA) is considering comments to their risk-focused draft guidance, “Laser-Assisted In Situ Keratomileusis (LASIK) Lasers-Patient Labeling Recommendations.” Although LASIK is one of the...more
On November 1, 2022, the Centers for Medicare & Medicaid Services (CMS) issued the 2023 Physician Fee Schedule (PFS) Final Rule. CMS publishes a PFS annually so as to make changes in federal healthcare reimbursement and...more
Last month, the U.S. Food and Drug Administration (FDA) issued a final guidance on drug and biologic submissions to the agency that include real-world data (RWD) and real-world evidence (RWE). The procedural guidance aims to...more
Conducting a clinical trial is a notoriously expensive endeavor that is necessary not only for ultimate drug approval, but even to progress to the next phase of drug investigation and development. An unfortunate consequence...more
The Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) updated its Guidance Agenda in June 2022, which provides that the agency plans to issue 18 guidance documents in 2022,...more
On June 30, 2022, California Governor Gavin Newsom signed into law SB 54, putting into place some of the nation’s strictest, far-reaching regulations on packaging materials. The legislation mandates significantly reduced use...more
On May 25, 2022, the U.S. Food and Drug Administration (FDA) issued a guidance document intended to help pharmacists and wholesale drug distributors understand and comply with its final rule regarding the import of certain...more
In May 2022, the Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA) announced the launch of a new program for expediting the development of new treatment options for rare...more
On May 4, 2022, the U.S. Food and Drug Administration (FDA) issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food,...more
Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October...more
4/26/2022
/ Consumer Product Safety Commission (CPSC) ,
Coronavirus/COVID-19 ,
Corporate Counsel ,
Department of Justice (DOJ) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Fraud ,
Opioid ,
Pfizer ,
Pharmaceutical Industry ,
Popular ,
Purdue Pharma ,
Vaccinations
On February 22, 2022, the U.S. Food and Drug Administration (FDA) hosted a webinar on two draft guidance documents for the transition plans for medical devices commercialized pursuant to either Emergency Use Authorization...more
On December 22, 2021, the U.S. Food and Drug Administration (FDA) issued two draft guidance documents for the transition plans for medical devices commercialized pursuant to either Emergency Use Authorization (EUA) or the...more
On June 7, 2021, the U.S. Food and Drug Administration (FDA) approved Biogen, Inc.'s Aduhelm (aducanumab) to treat Alzheimer's disease through the FDA Accelerated Approval Program in a landmark decision. The FDA's approval...more
In this issue, we discuss U.S. Food and Drug Administration (FDA) regulation of wellness devices. We also look at good commercial contracting hygiene for digital health start-ups. Other articles include recent enforcement...more
On March 22, 2021, the U.S. Food and Drug Administration (FDA) issued warning letters to two companies, Honest Globe Inc. and Biolyte Laboratories LLC, for selling products labeled as containing cannabidiol (CBD) in ways that...more