Novel Drug Approvals for 2024
Innovative drugs often mean new treatment options for patients and advances in health care for the American public.
UPDATED: Jarman’s Midwest Cleaning Systems, Inc. Issues Voluntary Nationwide Recall of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer & Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Due to Presence of Methanol
Canton, SD, Jarman’s Midwest Cleaning Systems, Inc. is voluntarily recalling all lots of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer…
FDA approves neoadjuvant and adjuvant pembrolizumab for resectable locally advanced head and neck squamous cell carcinoma
On June 12, 2025, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) for adults with resectable locally advanced head…
FDA Rare Disease Innovation Hub
FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER…
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
ANDA Assessment Program | GDUFA III Performance Goals and Program Enhancements
GDUFA III includes several enhancements to the ANDA assessment process to maximize the efficiency and utility of each assessment cycle.…
Newly Added Guidance Documents
Guidance documents represent the FDA’s current thinking on a particular subject. New guidance documents are listed here for three months.
Evaluation of spectroscopic techniques for on‐site drug testing of festival seizures
A two-fold on-site testing approach, Raman and FT-IR spectroscopy, was used to screen festival seizures. Moreover, FT-IR was combined with…
Mercaptans in malodorants break disulfide bridges in human serum albumin and form adducts suitable as biomarkers of exposure in vitro
Disulfide adducts of mercaptans with cysteine residues in human serum albumin were detected as tripeptides and dipeptides after proteolysis with…
Development and validation of general plasma screening method for performance enhancing drugs in racehorses utilizing liquid chromatography–high‐resolution mass spectrometry (LC–HRMS)
In this manuscript, a high-throughput automated assay based on liquid chromatography-high-resolution mass spectrometry (LC-HRMS) suitable for use as an initial…