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TXT Public Meeting on Device User Fee Reauthorization [83 Words] [ Price : $8.95]
Federal Register notice: FDA announces a 4/19 virtual public meeting entitled “Medical Device User Fee Amendments” to discuss proposed recommendations for the Medical Device User Fee Amendments reauthorization.
04/06/2022
 
 
TXT Info Collection on PET Drug GMPs [67 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection revision on positron emission tomography drug GMPs.
04/06/2022
 
 
TXT 40 Safety Signal Listings [2591 Words] [ Price : $8.95]
FDA releases the October-December 2021 safety signal report with 40 listings from the FDA Adverse Events Reporting System.
04/06/2022
 
 
TXT Medtronic Renal System Lowered Blood Pressure: Trial [2653 Words] [ Price : $8.95]
Medtronic says a clinical trial showed that patients who were prescribed anti-hypertensive medications and treated with its Symplicity Spyral Renal Denervation System continued to show durable, clinically significant blood pressure reductions through three years.
04/06/2022
 
 
TXT FDA OK’s Igalmi for Schizophrenia/Bipolar Agitation [252 Words] [ Price : $8.95]
FDA approves a BioXcel Therapeutics NDA for Igalmi (dexmedetomidine) sublingual film for the acute treatment of agitation associated with schizophrenia or Bipolar I or II disorder in adults.
04/06/2022
 
 
TXT FDA to Decide in June on Next Booster Compostion [430 Words] [ Price : $8.95]
FDA officials say that a decision will likely be made in June on whether a new Covid-19 booster composition is needed by November in time for any winter Covid surge.
04/06/2022
 
 
TXT Novartis Gene Therapy Facility Approved by FDA [2640 Words] [ Price : $8.95]
FDA gives commercial licensure approval to a second Novartis gene therapy manufacturing facility, this one in Durham, NC.
04/05/2022
 
 
TXT FDA Participating in EHR Integration Project [2664 Words] [ Price : $8.95]
FDA participates in the OneSource electronic health record data integration project.
04/05/2022
 
 
TXT Sotrovimab No Longer Authorized Anywhere [2648 Words] [ Price : $8.95]
FDA says GlaxoSmithKline’s sotrovimab is now not authorized for use in any HHS region because the proportion of Covid-19 cases from the omicron BA.2 sub-variant in all regions is above 50%.
04/05/2022
 
 
TXT CDER Head Looks to Improved Drug Safety Surveillance [1110 Words] [ Price : $8.95]
CDER director Patrizia Cavazzoni outlines budget priorities for FY 2023, including a priority to improve drug postmarket surveillance and oversight of marketed products.
04/05/2022
 
 
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