On November 12, 2025, the New England Journal of Medicine published an article authored by FDA Commissioner Marty Makary and Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad introducing the concept of...more
Though every new presidential administration creates new challenges—and opportunities—for businesses, the second Trump administration has proven to be particularly eventful for the life sciences industry. ...more
On July 16, 2025, President Trump signed into law the Halt All Lethal Trafficking of Fentanyl Act (HALT Fentanyl Act or the Act), which significantly reformed the 1970 Controlled Substances Act (CSA). The HALT Fentanyl Act...more
On September 3, 2025, the FDA announced the RDEP, a new framework intended to accelerate the approval of treatments for ultra-rare genetic diseases.1 The RDEP was jointly developed by the Center for Drug Evaluation and...more
On September 3, 2025, the US Food and Drug Administration (FDA) announced a new process to support the development of drugs intended to treat rare genetic diseases. The Rare Disease Evidence Principles (RDEP) process offers...more
Since taking the reins as FDA Commissioner, Dr. Martin Makary has repeatedly expressed an interest in new regulatory pathways, or new options for evidence generation, that would enable more flexible FDA review of...more
The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the Commissioner’s National Priority Voucher Program (CNPVP), designed to reward drug and biologic sponsors...more
More than two years after the passage of the Inflation Reduction Act (“IRA”) and the Centers for Medicare and Medicaid Services’ (“CMS’”) rapid implementation of the drug price negotiation program, the life sciences industry...more
Many life sciences stakeholders are familiar with “traditional” designation programs operated by the Food and Drug Administration (FDA) in exercising its medical product authorities, such as the orphan drug designation and...more
ACI and CRN are excited to welcome you back to New York City this Spring for our 12th Legal, Regulatory & Compliance Forum on Dietary Supplements. Network and collaborate with over 150 industry stakeholders to explore how...more
On February 12, the FDA issued a final rule regarding the use of Drug Master Files (“DMF”) in Biologics License Applications. DMFs are submissions to the FDA “used to provide confidential, detailed information about...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Psychedelics have the potential to treat chronic conditions such as post-traumatic stress disorder (PTSD), depression, obsessive-compulsive disorder (OCD), fibromyalgia, and various behavioral health conditions, yet...more
In a long-awaited milestone in the gene therapy space, the Food and Drug Administration (FDA) approved two gene therapies to cure sickle cell disease (SCD). Soon thereafter these approvals, a key licensing agreement was...more
Gene therapy is part of a new wave of medicine that approaches disease treatment by addressing the root causes rather than focusing on treating or reducing symptoms. Currently, gene therapies are being developed for treatment...more
On September 19, FDA released a highly anticipated new draft guidance for industry titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory...more
The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more
ACI and CRN are excited to welcome you back to New York City this Spring for the 11th Legal, Regulatory & Compliance Forum on Dietary Supplements. Since last year, there have been numerous important developments...more
A district court in Utah recently dismissed claims brought against a biotechnology company and its officers under Section 10(b) of the Securities Exchange Act and Rule 10b-5 adopted thereunder. The order in Richfield v....more
While we know the old adage chicken soup “cures” the common cold, decades of federal Food Drug Administration (FDA) enforcement have taught the industry that selling food as a “cure” renders it subject to criminal...more
On Jan. 23, the Food and Drug Administration (FDA) finalized industry guidance for clinical research using cannabis and cannabis-derived compounds, Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical...more
In what could be a game-changer to the dietary supplement and food industry, the U.S. Food and Drug Administration (FDA or Agency) is proposing to amend the investigational new drug (IND) regulations to exempt clinical...more
As the industry readies itself for the January 2023 pilgrimage to the J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry team has prepared...more
The U.S. Food and Drug Administration (FDA) recently issued a revised version of the draft guidance “Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers,” which includes recommendations for...more
On September 27, the Food and Drug Administration (FDA) issued two Notices of Proposed Rule Making that would harmonize the FDA’s human subject protection regulations with the Federal Policy for the Protection of Human...more