The U.S. Food and Drug Administration (FDA) recently released a draft guidance describing its proposed approach to reviewing and authorizing a predetermined change control plan (PCCP) in a marketing submission for a device...more
Wilson Sonsini’s inaugural Biotech Summit will address topics of critical importance to Biotech and Biopharmaceutical companies, including early and late-stage venture financing, partnering strategies, current and future AI...more
8/14/2024
/ Acquisitions ,
Antitrust Provisions ,
Artificial Intelligence ,
Biopharmaceutical ,
Biotechnology ,
Business Strategies ,
Capital Markets ,
CEOs ,
Collaboration ,
Early Stage Companies ,
Entrepreneurs ,
Events ,
Exit Strategies ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Initial Public Offering (IPO) ,
Intellectual Property Protection ,
Investment Opportunities ,
Investors ,
Life Sciences ,
Mergers ,
Partnerships ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Startups ,
Therapeutic Services ,
Venture Capital
As part of the Real-World Evidence Program, the U.S. Food and Drug Administration (FDA) has released the final guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory...more
Further to the guiding principles on the use of artificial intelligence (AI) and machine learning (ML) technologies jointly published by the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s...more
On June 28, 2024, the U.S. Supreme Court unequivocally declared “Chevron is overruled.” In Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce,1 the 6-3 majority dismantled the administrative...more
The U.S. Food and Drug Administration (FDA) is reaffirming its plans to actively regulate certain laboratory developed tests (LDTs) that the FDA has historically treated with enforcement discretion. On June 25, 2024, the FDA...more
Wilson Sonsini’s 31st Annual Medical Device & Digital Health Conference will address topics of critical importance to medical device and digital health companies, including early and late-stage venture financing, partnering...more
5/15/2024
/ Acquisitions ,
Artificial Intelligence ,
Best Practices ,
Business Strategies ,
Business Valuations ,
Compensation ,
Data Privacy ,
Digital Health ,
Early Stage Companies ,
Events ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Innovation ,
Investment Management ,
Investment Opportunities ,
Investment Portfolios ,
Investors ,
Life Sciences ,
Med Tech ,
Medical Devices ,
Mergers ,
Reimbursements ,
Startups ,
Strategic Partnerships ,
Venture Capital
This issue features articles on the firm’s Business Advisory Practice supporting Nervosave Therapeutics’ U.S. expansion; the USPTO’s forthcoming guidance on AI innovation protection; option pool sizes for life sciences...more
On November 7, 2023, the Federal Trade Commission (FTC) sent notice letters1 to 10 brand drug manufacturers of drug-device combination products, including drugs delivered by asthma inhalers, epinephrine autoinjectors, and...more
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
Last week, the California legislature approved Assembly Bill 418, the California Food Safety Act (AB 418), which is headed to Governor Gavin Newsom to sign or veto by October 14, 2023....more
On September 12, 2023, the U.S. Food and Drug Administration (FDA) issued warning letters to eight companies, including two major drugstore retail chains, for their involvement in the production or promotion of unapproved...more
Listening Sessions on Drug Price Negotiations Will Be Live Streamed and Opened to the Public This Fall -
In this Alert, we provide an update regarding the first 10 drugs for Medicare price negotiation selected under the...more
Wilson Sonsini’s 30th Annual Medical Device Digital Health Conference will address topics of critical importance to medical device and digital health companies today, including key healthcare regulatory considerations, the...more
5/24/2023
/ Acquisitions ,
Angel Investors ,
Artificial Intelligence ,
Business Development ,
Business Opportunities ,
Business Strategies ,
Business Valuations ,
Celebrity Endorsements ,
Data Privacy ,
Digital Health ,
Early Stage Companies ,
Endorsements ,
Entrepreneurs ,
Events ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Technology ,
Influencers ,
Innovation ,
Investors ,
IP Portfolio ,
Life Sciences ,
Machine Learning ,
Marketing ,
Med Tech ,
Medical Devices ,
Mergers ,
Partnerships ,
Professional Networking ,
Startups ,
Venture Capital
On February 24, 2023, the Federal Circuit held that Jazz Pharmaceuticals, Inc. (Jazz) must delist U.S. Patent No. 8,731,963 (the ’963 Patent) from the U.S. Food and Drug Administration’s (FDA’s) “Orange Book” because the...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
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
Effective January 1, 2023, California Assembly Bill 1278 requires California-licensed physicians and surgeons, including physicians and surgeons licensed under the Medical Practice Act or the Osteopathic Act (but excluding...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
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