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Santhera Pharma Delays NDA Over Inspection Readiness

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Santhera Pharmaceuticals says that a planned NDA submission for vamorolone in Duchenne muscular dystrophy has been postponed by fo...

100 Members of Congress Want HHS to Lower Drug Prices

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Some 100 members of Congress call on HHS to use existing legal authorities to lower drug prices in the U.S.

Priority Voucher Redeemed for Alexions Ultomiris

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Federal Register notice: FDA announces the approval of product that redeemed a priority review voucher AstraZencas sBLA for Ultom...

GE Carescape Ventilator Recall is Class 1

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FDA says the GE Healthcare recall of its Carescape R 860 ventilator due to issues with its backup and replacement backup batteries...

Expert Compounding Pharmacy FDA-483

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FDA releases an FDA-483 with six observations from an inspection at Lake Balboa, CA-based Expert Compounding Pharmacy, a producer ...

FDA Updates Digital Health Center of Excellence Activities

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FDA updates activities in the Digital Health Center of Excellence.

OSE Using Artificial Intelligence to Aid Drug Surveillance

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CDER Office of Surveillance and Epidemiology staffer Oanh Dang explains how drug safety analysts are using an information visualiz...

FDA Announces Pilots on CMC Changes, Hybrid Inspections

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FDA announces two new pilot programs that the International Coalition of Medicines Regulatory Authorities (ICMRA), of which the ag...

Gilead Resubmits NDA for HIV Therapy

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Gilead Sciences refiles an NDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for treating HIV-1 infecti...

Panel Recommends Omicron-based Covid Booster Vaccines

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FDAs Vaccines and Related Biological Products Advisory Committee votes 19 to 2 to recommend that the SARS-CoV-2 strain composition...