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TXT FDA WEBVIEW CLOSED FOR MLK DAY [29 Words] [ Price : $8.95]
FDA Webview’s newsroom closes Monday (1/15) in observance of Martin Luther King day.
01/12/2018
 
 
TXT Expanded Use for AstraZeneca’s Lynparza in Breast Cancer [407 Words] [ Price : $8.95]
FDA expands the approved use of AstraZeneca’s Lynparza (olaparib tablets) to include treating patients with certain types of breast cancer that have metastasized and whose tumors have a specific genetic mutation.
01/12/2018
 
 
TXT Regulatory Review Period Determined for Uromedica’s Proact [117 Words] [ Price : $8.95]
Federal Register notice: FDA determines that the regulatory review period for Uromedica’s Proact Adjustable Continence Therapy For Men was 3,892 days.
01/12/2018
 
 
TXT Comments Extended for Guide on Submitting ANDA/505(b)(2) [84 Words] [ Price : $8.95]
Federal Register notice: FDA reopens the comment period until 2/12 on a draft guidance on “Determining Whether to Submit an ANDA or a 505(b)(2) Application.”
01/12/2018
 
 
TXT Comments Extended on Orphan Drug Guidance [66 Words] [ Price : $8.95]
Federal Register notice: FDA extends the comment period on a draft guidance entitled “Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.”
01/12/2018
 
 
TXT CDER Easing Bioequivalence for Inhaled Drugs [483 Words] [ Price : $8.95]
An new CDER regulatory science report details the agency’s efforts to ease bioequivalence requirements for locally-acting orally inhaled and nasal drug products.
01/12/2018
 
 
TXT Guide on Device UDI Enforcement [1229 Words] [ Price : $8.95]
FDA posts a guidance on “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices.”
01/12/2018
 
 
TXT FDA Delays ‘Intended Use’ Changes to Review Stakeholder Concerns [737 Words] [ Price : $8.95]
FDA delays the effective date of portions of a final rule that would have revised the agency’s existing regulations describing the types of evidence that may be considered in determining a medical product’s intended use.
01/12/2018
 
 
TXT Public Citizen Seeks Ban on HES Intravenous Solutions [244 Words] [ Price : $8.95]
Public Citizen questions FDA’s delay in banning from the market all hydroxyethyl starch intravenous solutions, a move the European Medicines Agency recommended 1/12.
01/12/2018
 
 
TXT FDA Approves GSK Expanded Use for Fluarix Vaccine [1150 Words] [ Price : $8.95]
FDA approves a GlaxoSmithKline supplemental BLA for an expanded indication for Fluarix Quadrivalent (influenza vaccine) to include use in those six months and older.
01/12/2018
 
 
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