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TXT Praise for PDUFA, Suggestions for Improvement [2991 Words] [ Price : $8.95]
Five major stakeholders praise PDUFA performance to date and suggest improvements to be included in the 2022 PDUFA 7 reauthorization.
08/26/2020
 
 
TXT Trump Turned Science into ‘Political Hot Potato’: Op-Ed [3058 Words] [ Price : $8.95]
Former FDA commissioner Margaret Hamburg and principal deputy commissioner Joshua Sharfstein say the Trump administration and FDA can’t afford to repeat the mistakes in the way the recent EUA for convalescent plasma was decided and announced.
08/26/2020
 
 
TXT Ipsen Plans Palovarotene NDA After Post Hoc Analysis [234 Words] [ Price : $8.95]
Ipsen says it is planning to submit an NDA for palovarotene and its use in treating patients with fibrodysplasia ossificans progressiva.
08/26/2020
 
 
TXT FDA Taking Steps on Rifampin, Rifapentine Shortages [2706 Words] [ Price : $8.95]
FDA says it will temporarily allow the distribution of some rifampin and rifapentine with nitrosamine impurities to avoid shortages while manufacturers work to reduce or remove the impurities.
08/26/2020
 
 
TXT Who is Helping Hahn with Communication Efforts? [509 Words] [ Price : $8.95]
FDA commissioner Stephen Hahn’s controversial remarks exaggerating the efficacy of convalescent plasma touches off a wider examination of those advising him with his communications efforts.
08/26/2020
 
 
TXT FDA Panels to Review Reformulated Oxycontin Studies [95 Words] [ Price : $8.95]
Federal Register notice: FDA announces a 9/10 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee.
08/25/2020
 
 
TXT Smiths Medical Recalls Medfusion Software [106 Words] [ Price : $8.95]
Smiths Medical recalls specific software versions used with its Medfusion 3500 and 4000 Syringe Pumps because of an error that may lead to fluid/medication over delivery or under delivery.
08/25/2020
 
 
TXT House E&C Committee Wants Politics Out of Vaccine [3086 Words] [ Price : $8.95]
Leaders of the House Energy and Commerce Committee ask FDA commissioner Stephen Hahn what steps he is taking to ensure that science prevails over political pressure in consideration of Covid-19 vaccines.
08/25/2020
 
 
TXT HCT/Ps Violations at 2 Banco Vida Facilities [2994 Words] [ Price : $8.95]
FDA warns Puerto Rico’s Banco Vida Corp. about violations involving its umbilical cord blood products.
08/25/2020
 
 
TXT Wintac Warned on CGMP Inspection Violations [2704 Words] [ Price : $8.95]
FDA warns Wintac Limited about CGMP violations in its production of finished drugs at a facility in Bangalore, India.
08/25/2020
 
 
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