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© 2022 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2022 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
May 17, 2022
In this episode of the Drug Solutions Podcast, Chris Spivey, editorial director, interviews Michael Kopcha, Sau Lee, and Cindy Buhse of FDA about not being afraid to try new approaches and how they invite fresh ideas and abundant communication.
May 11, 2022
The agency’s Center for Drug Evaluation and Research has launched the new program to increase development of treatment options for patients with rare diseases.
The drug is the first immunomodulatory COVID-19 treatment approved by FDA.
May 03, 2022
FDA has issued the final guidance on electronic postmarketing safety reports in a series of guidance documents.
May 02, 2022
The move toward using the Digital Application Dataset Integration (DADI) project for the initial implementation of IDMP-based regulatory data submissions offers both opportunities and challenges for pharmaceutical organizations.
What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?
April 22, 2022
FDA is requesting comment on draft document “Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange.”
March 21, 2022
Moderna, Pfizer, and BioNTech are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines.
March 04, 2022
FDA’s CDER continues to make rare diseases a priority with drug approvals and programming to speed therapeutic development.
EMA’s PRIME scheme has enabled life-changing medicines to become available to patients at a faster rate.