PharmaRadar360

PharmaRadar360

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Pipeline and approval signals

Search agency notices, approvals, recalls, and regulatory updates from global authorities.

1,100 of 1,100 tracked regulatory updates from 40 agencies and publishers, page 15 of 22.

All 1,100FDA 89EMA 7MHRA 60PMDA 31UKHSA 60DHSC 60Health Canada 60EOF Greece 60
FDAUnited StatesOct 23Drug label update: OxcarbazepineopenFDA Drug LabelsFDAUnited StatesOct 23Drug label update: CarbamazepineopenFDA Drug LabelsFDAUnited StatesOct 23Drug label update: Sertraline HClopenFDA Drug LabelsFDAUnited StatesOct 23Drug label update: LAXATIVEopenFDA Drug LabelsFDAUnited StatesOct 23Drug label update: CVS Diphenhydramine HydrochlorideopenFDA Drug LabelsFDAUnited StatesOct 23Drug Alerts and StatementsFDA Drug Safety CommunicationsFDAUnited StatesOct 21Wedgewood Pharmacy Issues Recall of Certain Compounded Veterinary Medications Within Expiry Due to Potential Potency IssuesFDA MedWatchFDAUnited StatesOct 21Drug recall: Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.openFDA Drug RecallsFDAUnited StatesOct 21Drug recall: HYDROCORTISONE SODIUM SUCCINATEopenFDA Drug RecallsFDAUnited StatesOct 21Drug recall: METOCLOPRAMIDEopenFDA Drug RecallsFDAUnited StatesOct 21Device recall: Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395AopenFDA Device RecallsFDAUnited StatesOct 21Device recall: FORWARD Gunshot Wound Kit; Model: AFT-GSW;openFDA Device RecallsFDAUnited StatesOct 21Device recall: IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50 through R89, PACS-5-6-1-R41 through R81, PACS-5-7-1-R21 through R61, PACS-5-8-1-R2 through R42, PACS-5-9-1-R8 through R19; SyopenFDA Device RecallsFDAUnited StatesOct 21Device recall: Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY DYNJ906731MopenFDA Device RecallsFDAUnited StatesOct 21Device recall: Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline Product number/SKU DYNJT5715A; 3) CABG ACCESSORY PACK, Medline Product number/SKU DYNJ85751; 4) OPEN HEART PACK, Medline Product numopenFDA Device RecallsFDAUnited StatesOct 21Device recall: TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.openFDA Device RecallsFDAUnited StatesOct 21Device recall: Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order Number (GPN) G16112openFDA Device RecallsFDAUnited StatesOct 21Device recall: Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct wopenFDA Device RecallsFDAUnited StatesOct 21Device recall: iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)openFDA Device RecallsFDAUnited StatesOct 21Device recall: Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium, Item No. 0015821openFDA Device RecallsFDAUnited StatesOct 21Device recall: REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mmopenFDA Device RecallsFDAUnited StatesOct 21Device recall: HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)openFDA Device RecallsFDAUnited StatesOct 21Device recall: DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513openFDA Device RecallsFDAUnited StatesOct 21Device recall: RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115openFDA Device RecallsFDA Law BlogUnited States1d agoA Day Late, A Buck Short: Or How to Lose PTE Without Really TryingHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited States2d agoThe Flexibility Papers, No. 2: Beyond Listening—Making Patient Input MatterHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited States5d agoDEA Clarifies Direct Delivery of Prescribed Controlled Substances to PractitionersHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited States6d agoThe Flexibility Papers, No. 1: First Principles for a Rare Disease FrameworkHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesOct 29The PEPTIDE-L Wave Reaches HHS: Enforcement Discretion … Not the Finish LineHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesOct 27Six-Month Window: DOJ and HHS Launch Healthcare FCA Self-Disclosure PilotHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesOct 26If You Change It, FDA Will Come: What the O.N. Diagnostics Warning Letter Means for SaMD ModificationsHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesOct 23DOJ’s New Whistleblower Program: Fast Cash for Fraud TipsHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesOct 20Renewal Season is Here! FY 2027 Device Establishment Registration and ListingHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesOct 19CDRH’s FY 2027 Proposed Guidances: Shorter Lists, Focused on Software and AIHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesOct 16CMS Gains Permissive Exclusion Authority: Implications for Pharma and Medical Device CompaniesHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesOct 15Rare Disease Refresh: FDA’s Rare Disease Framework InitiativeHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesOct 13“Biennial” v. “Biannual” in DEA WorldHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesOct 6Last One Standing: DOJ Narrows Fraud Enforcement Priorities to Companies that Violate the CSA and FDC ActHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesOct 2Another Win for HCT/P Manufacturers: Court Vacates and Remands FDA’s AXIOFILL DeterminationHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesSep 28Common Regulatory Deficiencies of Hospital Employee DiversionHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesSep 25Nothing to See Here: FDA Issues Interchangeable Biosimilars Strategy DocumentHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesSep 23T Time: Women Were First to Put Testosterone Back on FDA’s Agenda. Now It’s Industry’s TurnHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesSep 15Dompé U.S. Pays $32 Million to Resolve Co-Pay Foundation Kickback Allegations Following Voluntary Self-DisclosureHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesSep 14Confirmatory Evidence for All? FDA’s Approval of Lytenava for Wet AMD Shows How Non-Rare Diseases Can Use Confirmatory Evidence and That “Failed” Studies Can Provide Confirmatory EvidenceHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesSep 8FDA and SEC Compare Notes: What the New MOU Means for FDA-Regulated Public CompaniesHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesSep 4HPM Presenting at IQVIA Annual Controlled Substances & State Regulatory Conference (Sept. 16-18)Hyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesSep 3Regulating a Moving Target – FDA Seeks Comments on Possible Framework for Regulation of GenAIHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesSep 2OPDP’s Latest Reminder on Preapproval PromotionHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesAug 30ACI’s 6th Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIAHyman, Phelps & McNamara (FDA Law)FDA Law BlogUnited StatesAug 28The CMP Plot Thickens: Solicitor General Letter Casts FDA’s Tobacco Civil Money Penalty Scheme into Further DoubtHyman, Phelps & McNamara (FDA Law)