The Food and Drug Administration (FDA) has begun 2026 with a clear signal to the direct‑to‑consumer testing industry: self‑collection devices remain firmly within the agency’s regulatory reach, notwithstanding the 2025 court...more
On January 6, the Food and Drug Administration (FDA) updated its guidance documents on Clinical Decision Support (CDS) software and general wellness products, and withdrew its guidance on the adoption of international...more
Last week, FDA released draft guidance titled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies.” This draft...more
On September 30, 2025, the Food and Drug Administration (FDA) published a Request for Public Comment to obtain feedback from interested parties on current approaches to measuring and evaluating the performance of AI-enabled...more
On Tuesday, September 23, 2025, FDA published guidance titled “Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency.” The guidance, a draft of which was published on May...more
Recently, it was reported that the U.S. Food and Drug Administration (FDA) is launching two cross-agency artificial intelligence (AI) councils. One AI council will be tasked with addressing how the agency uses AI internally...more
This morning, the U.S. Food and Drug Administration (FDA) announced the publication of more than 200 decision letters, also known as complete response letters (CRLs), with plans to release more from the archives. The CRLs...more
On June 24, 2025, in a hearing before the U.S. House of Representatives Committee on Energy and Commerce, the Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr. revealed that his department plans to soon...more
Over the weekend, the Department of Justice (DOJ) did not file an appeal of the U.S. District Court for the Eastern District of Texas’ decision to vacate and set aside the agency’s final rule on the regulation of laboratory...more
On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as...more
On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets...more
United States Department of Health and Human Services (HHS) Secretary Kennedy recently directed the U.S. Food and Drug Administration (FDA) to consider rulemaking to revise its longstanding regulations and guidance governing...more
On January 6, the FDA announced the availability of draft guidance on accelerated approval for drugs and biological products, and consideration for determining whether a confirmatory trial is underway. Under the Consolidated...more
On December 5, 2024, FDA unveiled the draft guidance for industry regarding accelerated approval for drugs and biologics. This guidance provides additional information regarding the development of drugs and biologics to treat...more
On September 20, 2024, the U.S. Food and Drug Administration (FDA) approved the first influenza (flu) vaccine for at‑home use. The vaccine, FluMist, is administered by nasal spray and prevents the flu by using a weakened...more
On October 7, 2024, FDA granted marketing authorization for the over‑the‑counter combination flu and COVID-19 combination test, Healgen Rapid Check COVID-19/Flu A&B Antigen Test. Although other at‑home combination tests...more
On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the longstanding Chevron doctrine, under which courts generally granted deference to a federal agency’s reasonable interpretation of ambiguous...more
7/9/2024
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Chevron Deference ,
Chevron v NRDC ,
Corner Post Inc v Board of Governors of the Federal Reserve System ,
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Food and Drug Administration (FDA) ,
Government Agencies ,
Healthcare ,
Judicial Authority ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
SCOTUS ,
Statutory Interpretation
On May 16th, the U.S. Drug Enforcement Administration (DEA) issued a Notice of Proposed Rulemaking (NPRM) to initiate the rescheduling of marijuana from a Schedule I to a Schedule III drug. The NPRM, which was published in...more
5/31/2024
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Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Farm Bill ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Internal Revenue Code (IRC) ,
Marijuana ,
Notice of Proposed Rulemaking (NOPR) ,
Regulatory Reform ,
Schedule I Drugs
On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests (LDTs). Set to be officially published on May 6, this...more
Key Points - The scientific review supporting HHS’s recommendation to DEA that cannabis be reclassified from a Schedule I to a Schedule III drug was published on January 12, 2024. Classifying cannabis as a Schedule III...more
2/26/2024
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Biden Administration ,
Cannabis Products ,
Controlled Substances Act ,
DEA ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
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Popular ,
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Schedule I Drugs
In January, the U.S. Food and Drug Administration (FDA) kicked off the year by announcing a much-anticipated proposal to restructure their human foods program (HFP), and the agency has continued to work on the details of...more
On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the Verifying Accurate,...more
On February 1, 2023, the Federal Trade Commission (FTC) announced that it had taken enforcement action against prescription drug discount company GoodRx, which agreed to injunctive relief and to pay a $1.5 million civil...more
On January 31, 2023, the U.S. Food and Drug Administration (FDA) announced a proposal to restructure the agency’s human foods program. FDA regulates almost 80 percent of the nation’s food supply and this work is a cornerstone...more
The U.S. Food and Drug Administration (FDA) announced the conclusion of an internal working group that cannabidiol (CBD) will require a new regulatory pathway. The FDA explicitly denied three citizen petitions urging the...more