Quality Systems

Chris Spivey is the editorial director of 

Podcasts

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.

Drug Solutions Podcast: FDA Weighs in on Advancing the Science of Pharmaceutical Manufacturing

Articles

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.

FDA Launches Accelerated Rare Disease Cures Program

The drug is the first immunomodulatory COVID-19 treatment approved by FDA.

FDA Approves Olumiant (baricitinib) to Treat COVID-19 in Hospitalized Adults

FDA has issued the final guidance on electronic postmarketing safety reports in a series of guidance documents. 

FDA Issues Final Guidance on Electronic Postmarketing Safety Reports

Renato Rjavec is director of product management at Amplexor Life Sciences.

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 DADI Means for the Pharmaceutical Industry

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?

FDA and Industry Prepare for Transition from Emergency Use Authorizations

FDA is requesting comment on draft document “Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange.”

FDA Requesting Comment on Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Exchange 

Moderna, Pfizer, and BioNTech are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines.

COVID-19 Vaccine Manufacturers Submit Appeals to FDA for Fourth Dose

FDA’s CDER continues to make rare diseases a priority with drug approvals and programming to speed therapeutic development.

FDA Continues to Make Rare Diseases a Priority with Speedy Therapeutic Development

EMA’s PRIME scheme has enabled life-changing medicines to become available to patients at a faster rate.

Regulatory Filings and Submissions