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 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 On April 3, 2023, the FDA released draft guidance titled “Marketing Submission...more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
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The U.S. Food and Drug Administration (FDA) is considering comments to their risk-focused draft guidance, “Laser-Assisted In Situ Keratomileusis (LASIK) Lasers-Patient Labeling Recommendations.”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
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 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
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
In a move welcomed by industry, the Food and Drug Administration (FDA) has granted six additional months of enforcement discretion to manufacturers of certain human cell, tissue, or cellular or tissue-based products (HCT/Ps)....more
On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), a $2 trillion stimulus package thought to be the largest in U.S. history. This is the third stimulus package adopted...more
USJMF and Wilson Sonsini Host Successful Japan Trade Mission and Roadshow for U.S. Medtech Companies -
On November 5-11, 2019, U.S.-Japan Medtech Frontiers (USJMF) and Wilson Sonsini led a group of representatives from 22...more
1/7/2020
/ Biologics ,
Collaboration ,
Digital Health ,
FDA Approval ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Healthcare ,
Innovation ,
Investors ,
Japan ,
Life Sciences ,
Medical Devices ,
Startups ,
Venture Capital
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