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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
April 14, 2021
Patrizia Cavazzoni will become the director of the Center for Drug Evaluation and Research, and Janet Woodcock remains in limbo as the temporary head of FDA.
April 13, 2021
Acting FDA commissioner announces permanent appointment of Patrizia Cavazzoni as CDER director, following year-long acting-director role.
CDC and FDA are reviewing data from reported cases of a rare type of blood clot in people that received the Johnson & Johnson COVID-19 vaccine.
April 12, 2021
FDA has accepted Airway’s investigational new drug application for the development of its novel human recombinant protein, AT-100 (rhSP-D), as a treatment for COVID-19.
April 09, 2021
Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.
April 05, 2021
The first revision further clarifies the number of doses per vial for the vials that are already available, while the second revision allows for the availability of an additional multi-dose vial.
April 02, 2021
Concerns over vulnerability in the supply chain has increased pressure on FDA to renew site visits of domestic and foreign facilities.
April 01, 2021
A slew of solid-dose drug recalls were issued over the course of 2020 and in early 2021 after nitrosamine contamination was found in products.
March 29, 2021
EMA has approved the manufacturing of drug product for BioNTech’s COVID-19 vaccine, BNT162b2, at BioNTech’s manufacturing site located in Marburg, Germany.
The need for added revenues to fund billion-dollar infrastructure improvements has fueled challenges to industry pricing practices.