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NewsFDA Opens eCTD v4.0 Sample Submission Pathway to Reduce Technical Filing Errors
FDA's eCTD v4.0 sample submission program lets sponsors validate technical conformance before official filing, with feedback typically within 30 days.
FDA Issues Draft Guidance on Essential Drug Delivery Performance Characteristics for Combination Products
FDA Activates eCTD v4.0 Forward Compatibility for NDAs, ANDAs, BLAs, and INDs
Insmed Gains FDA Priority Review for ARIKAYCE sNDA
FDA Confirms RX7 Articulaciones Contains Undeclared Diclofenac and Dexamethasone
Latest news
11 storiesFDA Confirms Ort-Flx Contains Undeclared Diclofenac, Dexamethasone, and Methocarbamol
FDA lab analysis confirms Ort-Flx contains undeclared diclofenac, dexamethasone, and methocarbamol, triggering MedWatch reporting obligations.
Azora Therapeutics Appoints New Executive Team to Advance AT177
Azora Therapeutics rebrands from Adial Pharmaceuticals and names new leadership as AT177 Phase 1 targets H1 2027.
FDA Biosimilar Approval Tracker Shows 30-Plus Products Cleared Since Mid-2024
FDA has cleared 30-plus biosimilars since mid-2024, spanning denosumab, ranibizumab, insulin aspart, and oncology biologics.
FDA Refreshes Drug Approvals Portal With 20+ Regulatory Tools
FDA consolidates 20+ regulatory databases on one page, covering REMS, Orange Book, drug shortages, and postmarketing commitments.
FDA Cures Act Expands EUA Powers and MCM Review Vouchers
The 21st Century Cures Act grants FDA authority to waive cGMP requirements under EUAs and establishes a priority review voucher program for MCM manufacturers.
FDA Reissues Tropical Disease Priority Review Voucher Guidance
FDA reissues guidance on tropical disease priority review vouchers under FDAAA section 524, clarifying eligibility and award criteria for sponsors.
Benitec Reports 100% Response Rate in BB-301 OPMD Trial
Benitec's BB-301 achieves 100% response rate across both dose cohorts in OPMD, with a pivotal study planned for mid-2027.
Teva Acquires BioXcel's BXCL501 Assets for At-Home Treatment
Teva acquires BioXcel assets, advancing a late-stage at-home acute agitation treatment with complex device-drug combination regulatory implications.
Sudeep Pharma Gains FDA Approval for Nandesari Gujarat Facility
Sudeep Pharma secures FDA approval for its Nandesari, Gujarat facility, with US commercial supplies targeted for H2 FY27.
Jubilant Biosys Appoints Dr. SK Dhakshinamoorthy as Senior VP
Jubilant Biosys appoints Dr. SK Dhakshinamoorthy as Senior VP of Strategy and Value Creation, signalling a formalised capability expansion agenda.
FDA Renews Peripheral and CNS Drugs Advisory Committee
FDA has renewed the Peripheral and CNS Drugs Advisory Committee charter, resetting a two-year cycle governing neurological drug advisory reviews.
Worth your time this week
FDA Compliance Policy Guides Shape Drug Plant Inspections
Amgen Receives FDA Warning Letter Over Vectibix Video
FDA Flags NeilMed Glycerin Testing Failures in Warning Letter
