The Inflation Reduction Act of 2022 (the Act) includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, such as allowing the U.S. Department of Health...more
Spurred by President Biden's call for action to increase drug competition and a 2021 letter addressed to the U.S. Patent and Trademark Office (USPTO) by Senators Leahy and Tillis requesting the USPTO "to take action 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 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On February 22, 2022, the U.S. Food and Drug Administration (FDA) hosted a webinar on two draft guidance documents for the transition plans for medical devices commercialized pursuant to either Emergency Use Authorization...more
Wilson Sonsini is pleased to present the latest edition of The Life Sciences Report. This issue features an interview with Foresight Diagnostics co-founder and CEO Jake Chabon conducted by Matthew Meyer, the firm’s Chief...more
Some Worry Reduction in Pharmaceutical Revenues May Impact New Drug R&D and Innovation -
Lowering prescription drug pricing has been a hotly debated issue well before 2022 and is expected to continue in 2022. In November...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
In September 2021, the Office of Scientific Investigations of the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) issued a Warning Letter to dietary supplement company RAAS Nutritionals,...more
Starting in July of this year, China initiated a patent registration platform that bears some similarity to the generic drug framework under the Hatch-Waxman Act in the U.S. The purpose of this alert is to describe this new...more
Also Codifies FDA's Longstanding "Active Moiety" Approach for New Chemical Entity Exclusivity -
In April 2021, President Biden signed two bipartisan bills that aim to promote drug competition and to reduce prescription...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
On November 20, 2020, the Department of Health and Human Services (HHS) announced it was terminating the U.S. Food and Drug Administration's (FDA) Unapproved Drugs Initiative (UDI), which is further described in...more
This Client Advisory addresses some frequently asked questions for SARS-CoV-2 diagnostic test developers and provides an overview of recent updates relating to Emergency Use Authorizations (EUAs) published by the U.S. Food...more
This Client Advisory answers some frequently asked questions about the Public Readiness and Emergency Preparedness (PREP) Act and provides practical considerations for manufacturers, distributors, suppliers, healthcare...more
The U.S. Food and Drug Administration (FDA) issued a guidance in June 2020 that sets forth recommendations for manufacturers of drug and biological products to ensure compliance with current good manufacturing practice (cGMP)...more
During this unprecedented time, digital health is disrupting our healthcare delivery system for the better. Digital health companies are working hard to provide innovative telehealth, digital screening, and testing services....more
Navigating the U.S. Healthcare Regulatory Landscape for Wearable Devices -
Complex Environment Includes Key Federal Agencies FDA, FTC, OCR, CPSC, CMS, and OIG -
The wearable device market is emerging as a key player...more
6/19/2019
/ Biotechnology ,
California Consumer Privacy Act (CCPA) ,
Centers for Medicare & Medicaid Services (CMS) ,
Consumer Product Safety Commission (CPSC) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Technology-Assisted Review ,
Telemedicine ,
Value-Added Services
The U.S. Food and Drug Administration (FDA) recently released draft guidance on the new "Breakthrough Devices Program," which was established by the 21st Century Cures Act. This new program supersedes and combines features of...more