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
A selection of recent published briefs; this is not a complete archive.
FDA issues warning letter and import alert to Indian contract drug manufacturer for records access refusal
FDA's Center for Drug Evaluation and Research issued a warning letter on February 13, 2025, to Zenzi Pharmaceutical Industries Pvt. Ltd. in Maharashtra, India, for refusing to provide records under the foreign records ac…
Read the full FDA Drug Regulation & Scheduling brief →FDA closes warning letter against Zenzi Pharmaceutical but maintains Import Alert 66-79 over inspection refusal
FDA's Center for Drug Evaluation and Research issued a closeout letter on September 18, 2026 to Zenzi Pharmaceutical Industries Private Limited, a Maharashtra-based drug manufacturer. The firm remains on Import Alert 66-…
Read the full FDA Drug Regulation & Scheduling brief →FDA approves belzutifan plus lenvatinib combination for advanced clear cell renal cell carcinoma in adults
The FDA approved belzutifan combined with lenvatinib on September 24, 2026, for adults with advanced renal cell carcinoma with a clear cell component. This expands the labeled indications for both agents. The approval es…
Read the full FDA Drug Regulation & Scheduling brief →FDA Class I recall removes all Automated Impella Controllers globally over purge flag failures linked to 37 injuries and three deaths
The FDA has classified Abiomed's removal of all Automated Impella Controllers as a Class I recall — its most serious designation — following purge flag component failures within the purge pressure sensor assembly. As of …
Read the full FDA Drug Regulation & Scheduling brief →FDA classifies Becton Dickinson convenience kit correction as Class I recall over sterility-compromised sodium chloride ampules
The FDA on September 24, 2026 elevated its August 18 Early Alert for Becton Dickinson convenience kits and procedure trays to a Class I recall classification. The affected kits contain sodium chloride ampules manufacture…
Read the full FDA Drug Regulation & Scheduling brief →FDA issues warning letter to Empower Pharmacy over compounding violations and patient safety deficiencies
FDA's Center for Drug Evaluation and Research issued Warning Letter 738238 to Empower Clinic Services, LLC dba Empower Pharmacy on September 18, 2026, citing serious manufacturing deficiencies identified during a Novembe…
Read the full FDA Drug Regulation & Scheduling brief →HHS opens public docket to determine regulatory framework for deceased donor islet cell therapies for Type 1 diabetes
HHS published a Request for Information on September 24, 2026, seeking data and comments on how to regulate deceased donor islet cells and islet cell products for Type 1 diabetes treatment. The docket specifically explor…
Read the full FDA Drug Regulation & Scheduling brief →FDA approves Onswik, the first once-weekly basal insulin for adults with type 2 diabetes
The FDA approved Onswik (insulin efsitora alfa-gobe) injection on September 24, 2026, as a long-acting insulin analog for glycemic control in adults with type 2 diabetes. This is the first once-weekly basal insulin to re…
Read the full FDA Drug Regulation & Scheduling brief →FDA grants full approval to lirafugratinib for FGFR-altered cholangiocarcinoma in previously treated adults
The FDA approved lirafugratinib (Lyrfigtu, Elevar Therapeutics) on September 23, 2026, as a kinase inhibitor for adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring a …
Read the full FDA Drug Regulation & Scheduling brief →FDA Drug Regulation & Scheduling release pending Cresthaven Analytics full analysis: Early Alert: Ventilator Issue from React Health
FDA Drug Regulation & Scheduling published a regulatory release titled 'Early Alert: Ventilator Issue from React Health'. Cresthaven Analytics' full intelligence brief is pending re-analysis; see the source link below fo…
Read the full FDA Drug Regulation & Scheduling brief →DEA proposes Schedule I placement for five tryptamine hallucinogens covering manufacture, distribution, research, and possession
The DEA published a proposed rule on September 23, 2026 to place 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT into Schedule I of the Controlled Substances Act. Finalization would impose the full Schedule I contr…
Read the full FDA Drug Regulation & Scheduling brief →FDA debars Sanjay Kumar for five years from importing drugs into the United States
FDA issued a final debarment order on September 23, 2026, barring Sanjay Kumar from importing or offering to import any drug into the United States for five years. The order follows Kumar's federal felony conviction for …
Read the full FDA Drug Regulation & Scheduling brief →FDA proposes replacing animal-testing terminology with nonclinical framework across drug safety regulations
FDA published a proposed rule on September 22, 2026 to replace references to animal tests and studies with nonclinical terminology across safety and reporting regulations. The proposal adds no new requirements. It aligns…
Read the full FDA Drug Regulation & Scheduling brief →FDA issues direct final rule replacing animal testing terminology with nonclinical across drug safety regulations
FDA issued a direct final rule on September 22, 2026 replacing references to animal tests and studies with "nonclinical tests and studies" across certain drug safety and reporting regulations, and substituting "preclinic…
Read the full FDA Drug Regulation & Scheduling brief →FDA issues CGMP warning letter to kdc/one Chatsworth for carcinogen contamination failures in OTC drug manufacturing
FDA's Center for Drug Evaluation and Research issued a warning letter on September 8, 2026 to kdc/one Chatsworth, Inc. after a March-April 2026 facility inspection. The letter cites two failures: the firm did not test fo…
Read the full FDA Drug Regulation & Scheduling brief →FDA warns Empower Pharmacy over mass compounding of semaglutide and tirzepatide copies without valid patient-specific prescriptions
FDA's Center for Drug Evaluation and Research issued Warning Letter 738238 on September 18, 2026 to Empower Clinic Services, LLC dba Empower Pharmacy in Houston, Texas. The letter cites production of compounded semagluti…
Read the full FDA Drug Regulation & Scheduling brief →FDA accepts first digital health technology LOI under ISTAND for rare neurological condition outcome measure
The FDA's ISTAND program accepted a letter of intent on September 22, 2026 for a wearable sensor-derived digital outcome measure quantifying foot drop severity in Charcot-Marie-Tooth disease type 1A clinical trials. This…
Read the full FDA Drug Regulation & Scheduling brief →FDA Drug Regulation & Scheduling release pending Cresthaven Analytics full analysis: Par Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Due to the Presence of Particulate Matte
FDA Drug Regulation & Scheduling published a regulatory release titled 'Par Health Issues Voluntary Nationwide Recall of Two Lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection Due to the Presence of Particulat…
Read the full FDA Drug Regulation & Scheduling brief →Otsuka ICU Medical recalls one lot of 0.9% Sodium Chloride Injection over potassium chloride mix-up risk
Otsuka ICU Medical LLC issued a voluntary nationwide recall on September 21, 2026 covering one lot of 0.9% Sodium Chloride Injection, USP, 100mL single pack. The affected lot may carry overwrap labeling from 10 mEq Potas…
Read the full FDA Drug Regulation & Scheduling brief →FDA classifies AVID Medical convenience kit correction as Class I recall over sterility failures in sodium chloride ampules
The FDA on September 21, 2026 elevated its classification of the AVID Medical convenience kit correction to Class I, its most serious recall tier. Affected kits across five model numbers contain Huons Co. sodium chloride…
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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 (Professional tier and above) real-time alerts.
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