Quality/GMPs

Build into the CMC strategy the ability to pivot and be flexible should the course change.

How have lessons from the pandemic influenced the way companies use technology to perform quality-control procedures?

A structured assessment process can determine compliance for lifecycle process validation.

May 03, 2022

FDA’s Office of Compliance has released its 2021 Annual Report, which highlights the agency’s successes in public health.

May 03, 2022

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

May 03, 2022

VYDURA has been granted marketing authorization by the European Commission for both acute treatment of migraine and prophylaxis of episodic migraine.

May 02, 2022

Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.

May 02, 2022

ENHERTU has been granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer.

May 02, 2022

FDA has granted regenerative medicine advanced therapy (RMAT) designation to Autolus’ CAR-T cell therapy obe-cel.

May 01, 2022

Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.

May 01, 2022

FDA is incentivizing drug manufacturers through higher data integrity requirements.

May 01, 2022

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

May 01, 2022

Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.