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TXT Complete Response for Akebia Vadadustat [2692 Words] [ Price : $8.95]
FDA issues a complete response letter for Akebia’s vadadustat citing a negative benefit/risk assessment and safety concerns.
03/30/2022
 
 
TXT Panel Votes 6 to 4 to Reject Amylyx ALS Drug [488 Words] [ Price : $8.95]
FDA’s Peripheral and Central Nervous System Drugs Advisory Committee votes 6 to 4 that data from a single randomized, controlled trial and an open-label extension study did not establish that Amylyx Pharmaceuticals’ AMX0035S therapy is effective in treating ALS patients.
03/30/2022
 
 
TXT Info Collection on Clinical Investigator Disclosures [132 Words] [ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled “Financial Disclosure by Clinical Investigators.”
03/29/2022
 
 
TXT FDA Provides More Details on Legislative Proposals [855 Words] [ Price : $8.95]
FDA releases an executive summary that provides more details on the package of legislative proposals that were included in the agency’s FY 2023 budget proposal for the agency, including expanded authority to enhance remote regulatory assessments that were widely used during the Covid-19 pandemic and more authority to ensure medical device firms implement cybersecurity protections.
03/29/2022
 
 
TXT CISA Philips e-Alert Advisory [2644 Words] [ Price : $8.95]
The federal Cybersecurity & Infrastructure Security Agency identifies a vulnerability in the Philips e-Alert MRI monitoring platform.
03/29/2022
 
 
TXT FDA Releases 2 FDA-483s for Zhejiang Hisun [2748 Words] [ Price : $8.95]
FDA releases the FDA-483 issued following two 2017 inspections at China’s Zhejiang Hisun Pharmaceutical Company.
03/29/2022
 
 
TXT CGMP Issues at Agropharma Laboratories [2826 Words] [ Price : $8.95]
FDA warns Salinas, Puerto Rico-based Agropharma Laboratories about repeat CGMP violations in its production of finished drugs.
03/29/2022
 
 
TXT FDA Approves 2nd mRNA Booster for Some Individuals [2705 Words] [ Price : $8.95]
FDA authorizes a second booster dose of the Pfizer and Moderna Covid-19 vaccines for older adults and some immunocompromised people.
03/29/2022
 
 
TXT Dr Retter CGMP Violations Cited [2858 Words] [ Price : $8.95]
FDA warns Mazowieckie, Poland-based Dr Retter Ec Wladyslaw Retter about CGMP violations in its production of over-the-counter drugs.
03/29/2022
 
 
TXT Comments on Computational Modeling Guidance [2677 Words] [ Price : $8.95]
Three stakeholders submit general and specific comments on an FDA computational modeling and simulation draft guidance.
03/29/2022
 
 
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