FDA Drug Regulation & Scheduling
Material regulatory developments from U.S. Food and Drug Administration and U.S. Drug Enforcement Administration are tracked daily by Cresthaven Analytics. Over the last 90 days, 20 material briefs relevant to professionals operating in the healthcare & life sciences sector have been published below. Each brief is sourced directly from the primary regulatory feed, summarized for institutional readers, and scored for materiality.
Recent material activity
-
Baxter recalls single lot of Cefazolin in Dextrose Injection over cardboard particulate contamination
Baxter International announced a voluntary nationwide recall on July 24, 2026 of one lot of Cefazolin in Dextrose Injection, USP, 2G/100mL, due to cardboard particulate matter found in solution. The recall covers Lot LD1…
Read a full sample brief → -
FDA issues Early Alert on Boston Scientific ENROUTE carotid neuroprotection systems over arterial sheath tip separation risk
FDA's Center for Devices and Radiological Health issued an Early Alert on July 24, 2026 for specific lots of the ENROUTE Transcarotid Neuroprotection System and ENROUTE Transcarotid Neuroprotection System Plus. Boston Sc…
Read a full sample brief → -
FDA grants full approval to zidesamtinib for ROS1-positive NSCLC following prior TKI therapy
The FDA approved zidesamtinib (Jideytro, Nuvalent, Inc.) on July 22, 2026 for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who had received at least one prior ROS1 tyrosine kinase i…
Read a full sample brief → -
FDA classifies diabetes digital behavioral therapeutic devices into Class II under special controls
On July 24, 2026, the FDA issued a final classification order placing diabetes digital behavioral therapeutic devices into Class II with special controls. The order establishes the regulatory pathway and codified special…
Read a full sample brief → -
FDA issues five-year import debarment order against Francis Esteban Matos following federal felony conviction
On July 24, 2026, FDA issued a final debarment order barring Francis Esteban Matos from importing or offering for import any drug into the United States for five years. The order follows a federal felony conviction for c…
Read a full sample brief → -
FDA amends advisory committee meeting notice for Replimune gene therapy BLA, updating dates and logistics
The FDA amended its June 30, 2026 Federal Register notice for the Cellular, Tissue, and Gene Therapies Advisory Committee meeting on Replimune's biologics license application for vusolimogene oderparepvec. The amendment …
Read a full sample brief → -
Sunny Pharmtech recalls three lots of injectable cyclophosphamide over steel particulate contamination
On July 24, 2026, the FDA published a voluntary nationwide recall by Sunny Pharmtech, Inc. covering three lots of Cyclophosphamide for Injection, USP in 1g/vial and 2g/vial presentations. The recall was triggered by conf…
Read a full sample brief → -
FDA issues draft guidance streamlining nonclinical safety studies for monospecific monoclonal antibodies
On July 24, 2026, FDA's Center for Drug Evaluation and Research released draft guidance on nonclinical safety study requirements for monospecific monoclonal antibodies. The guidance identifies conditions under which gene…
Read a full sample brief → -
FDA CDER issues draft guidance establishing a validation framework for new approach methodologies in drug development
FDA's Center for Drug Evaluation and Research published draft guidance on July 24, 2026, offering drug developers a validation framework and general recommendations for using new approach methodologies in place of, or al…
Read a full sample brief → -
FDA grants first OTC approval for a fixed-dose acetaminophen and naproxen sodium combination tablet
On July 24, 2026, FDA approved Tylenol with Naproxen as the first nonprescription fixed-dose combination tablet pairing acetaminophen 325 mg and naproxen sodium 110 mg. The approval creates a new OTC product category by …
Read a full sample brief → -
FDA CDER updates nitrosamine impurity acceptable intake limits and implementation timelines for human drug manufacturers
FDA's Center for Drug Evaluation and Research updated acceptable intake limits for nitrosamine drug substance-related impurities on July 24, 2026, revising the living reference table linked to final guidances issued in A…
Read a full sample brief → -
Sunny Pharmtech recalls three lots of injectable cyclophosphamide over steel particulate contamination
Sunny Pharmtech, Inc. has recalled three lots of Cyclophosphamide for Injection, USP — in 1g/vial and 2g/vial presentations — due to confirmed steel particulate matter in the product. FDA published the voluntary nationwi…
Read a full sample brief → -
FDA publishes CMC readiness strategy for accelerated-development drugs and biologics covering fiscal years 2026 and 2027
FDA's Strategy Document, published July 23, 2026, sets out completed actions and planned steps for fiscal years 2026 and 2027 to advance chemistry, manufacturing, and controls readiness for products on accelerated clinic…
Read a full sample brief → -
FDA publishes CDRP Strategy Document outlining CMC readiness actions for accelerated-development products
FDA's July 23, 2026 Strategy Document summarizes actions taken under the Chemistry, Manufacturing, and Controls Development and Readiness Pilot to support sponsors with accelerated clinical development timelines. The pil…
Read a full sample brief → -
FDA expands Pre-ANDA consultation program under GDUFA III to reduce generic drug assessment cycles
FDA published updated guidance on July 23, 2026 expanding the Pre-ANDA Program under the Generic Drug User Fee Amendments III commitment framework. The update restructures pre-submission consultation pathways for prospec…
Read a full sample brief → -
FDA publishes GDUFA III ANDA assessment program enhancements targeting reduced review cycles for generic drug applications
The FDA published updated guidance on July 23, 2026 describing enhancements to the ANDA assessment program under the Generic Drug User Fee Amendments III framework. These enhancements aim to reduce the number of assessme…
Read a full sample brief → -
FDA advises consumers against Kangaroo Intense Venus 3000 sexual enhancement product over undisclosed drug ingredient
On July 23, 2026, the FDA issued a consumer safety advisory warning against purchasing or using Kangaroo Intense Venus 3000, a sexual enhancement product sold online and potentially in retail stores. The advisory identif…
Read a full sample brief → -
FDA issues warning letter to Alembic Research Centre investigator over informed consent failures in bioequivalence study
FDA's Center for Drug Evaluation and Research issued a warning letter dated July 10, 2026 to clinical investigator Pratik Doshi, M.D. at Alembic Pharmaceuticals Ltd.'s Vadodara, India facility. The letter cites failure t…
Read a full sample brief → -
FDA determines RASUVO methotrexate 27.5 mg/0.55 mL withdrawal was not safety-driven, clearing ANDA pathway
On July 22, 2026, FDA determined that RASUVO (methotrexate) solution, 27.5 mg/0.55 mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination removes the regulatory barrier to ANDA approva…
Read a full sample brief → -
FDA CDER issues warning letter to Nu Skin Enterprises for drug listing failures across 64 products
FDA's Center for Drug Evaluation and Research issued a warning letter dated March 2, 2026 to NSE Products, Inc. DBA Nu Skin Enterprises, Inc. for drug listing violations under the Federal Food, Drug, and Cosmetic Act. Th…
Read a full sample brief →
Get every FDA Drug Regulation & Scheduling brief delivered the day it lands
From $149/month
Cresthaven Analytics monitors U.S. Food and Drug Administration and U.S. Drug Enforcement Administration continuously, applying institutional materiality scoring to every release. Subscribers receive structured briefs via email, portal, and (Executive tier and above) real-time alerts.
View all tiers →