Drugs
The U.S. Supreme Court has ruled in favor of Hikma Pharmaceuticals in a closely watched patent dispute involving a generic version of Amarin Pharma's blockbuster cardiovascular drug Vascepa, finding that Amarin failed to adequately plead a claim of patent infringement through active inducement. In a decision reversing
Devices
FDA has issued a guidance document outlining its intent to exempt several low-risk, unclassified medical devices from premarket notification requirements, a move aimed at reducing regulatory burdens on manufacturers while maintaining existing safety and quality controls. Under the guidance, FDA said it does not intend to enforce compliance with
Drugs
A Friends of Cancer Research white paper makes the case for improving FDA’s Biomarker Qualification Program (BQP) and suggests three ways the program could be strengthened. “More than a decade after its establishment,” the paper says, “the BQP has not consistently functioned as a predictable or broadly used pathway
Drugs
U.S. House lawmakers have unveiled bipartisan legislation aimed at expanding federal scrutiny of U.S. investments in China's biotechnology sector, arguing that American capital and expertise are accelerating the growth of a strategic industry that could undermine U.S. economic and national security interests. Reps. John Moolenaar
FDA Policy/General
Former Oncology Center of Excellence and short-time CDER director Richard Pazdur says it’s time to restructure the agency’s organization into various new Centers. As reported by MedCity News, Pazdur appeared on a STAT panel during but apart from the recent annual meeting of the American Society of
Drugs
In an effort to win back a constituency that has become disenchanted with FDA, acting commissioner Kyle Diamantas met on 6/3 with representatives from several advocacy groups that support people with rare diseases. Reuters reports that although Diamantas heads the agency’s food program and lacks the background traditionally
Drugs
A Senate Special Committee on Aging 6/3 hearing took testimony that older Americans are at risk of death by poisoning due to faulty drug supply chains. A Legis1 online report says an earlier committee hearing looked at foreign generic drug quality and drug labeling transparency. “Witnesses brought personal and
FDA Policy/General
FDA has issued an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease therapy Sucraid (sacrosidase) Oral Solution were false or misleading because they overstated the drug's benefits and omitted important risk information. In the just-posted letter, CDER’s Office of Prescription Drug
FDA Policy/General
FDA has issued a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aerosol after the company failed to respond to multiple agency requests for manufacturing records related to drug products sold in the U.S. In a just-posted 5/22 Warning Letter, FDA said Aeroflex
Drugs
FDA says a 3/17-3/21/2025 Bioresearch Monitoring Program inspection at HealthPartners Neuroscience Center Research and Innovation in St. Paul, MN, determined that the facility did not adhere to the applicable statutory requirements and applicable regulations governing the conduct of nonclinical laboratory studies. A 5/19 Warning Letter
Drugs
Two Morgan Lewis attorneys say that while a new FDA draft guidance on three-year new clinical investigation exclusivity “does not break much new ground, it nonetheless serves as a helpful resource for applicants of NDAs seeking the exclusivity as well as applicants of follow-on applications potentially impacted by
FDA Policy/General
Senate appropriators have postponed consideration of a fiscal 2027 spending bill that would fund FDA, after a broader dispute over a Republican reconciliation package forced the Senate Appropriations Committee to suspend its markup schedule for the week. The Senate Appropriations Committee had been scheduled to meet 6/4 to mark
Drugs
FDA says CDER has accepted the first letter of intent for an in silico drug development tool (DDT) into the Innovative Science and Technology Approaches for New Drugs (ISTAND) DDT qualification program. Accepting the letter of intent is the first of three steps the DDT must pass to be qualified
Drugs
FDA has accepted for priority review a Roche NDA for giredestrant, an investigational oral endocrine therapy that could become the first selective estrogen receptor degrader (SERD) approved for use in patients with early-stage estrogen receptor-positive breast cancer. The filing seeks approval of giredestrant as an adjuvant treatment for
Drugs
FDA has issued Cingulate a complete response letter (CRL) on the company's NDA for CTx-1301, an investigational treatment for attention-deficit/hyperactivity disorder. The agency’s concerns were limited to requests for additional chemistry, manufacturing and controls (CMC) information, according to the company, noting that the letter
Devices
FDA has issued an early alert regarding a potentially high-risk problem involving certain Abiomed catheter introducer kits used with the company’s Impella heart pump system, citing concerns about blood clot formation that could lead to serious vascular complications. The agency said it is aware that Abiomed has advised
Drugs
A 10/6-10/14/2025 FDA inspection at the Medline drug manufacturing facility in Waukegan, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs that were similar to violations found previously in other company units. A 5/28 Warning Letter says the two violations
Drugs
A 12/16-12/19/2025 FDA inspection at the Laboratorios Jaloma drug manufacturing facility in Oblatos, Guadalajara, Jalisco, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations. A 5/22 Warning Letter says the specific violations were: * failure to ensure that laboratory records included complete data derived
Drugs
FDA has published a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities: Questions and Answers, with answers to common questions about firms’ communication of health care economic information (HCEI) about their prescription drugs and medical devices to payors, formulary committees, or other similar entities
Drugs
FDA has released an International Council for Harmonization (ICH) guidance that establishes a global framework for using computational modeling and simulation in drug development, a move regulators hope will increase confidence in model-based evidence and expand its role in regulatory decision-making. The new guidance, M15 General Principles for
Drugs
FDA has released a draft guidance outlining how developers of genome-editing gene therapies can leverage existing scientific and manufacturing knowledge to streamline product development and regulatory review. The draft was issued as part of the current user fee agreement to provide recommendations on leveraging prior knowledge in cell and
Biologics
Former FDAer Peter Pitts, now president of the Center for Medicine in the Public Interest, writes that ALS (amyotrophic lateral sclerosis) “has become an important stress test for whether American regulatory institutions can adapt to 21st century biomedical science.” Writing in an open-source article in the Journal of the