Topic

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Articles

Documentation is crucial to equipment qualification, says Siegfried Schmitt, vice president, Technical at Parexel.

Principles of Equipment Qualification

Mike Hennessy Jr. is the President and CEO of 

Next year's "FDA Voices" series will cover core topics FDA staff are prioritizing.

Voice of Regulators

Jennifer Markarian is a contributing editor for 

Single-use systems can benefit from standardized risk assessment and analysis protocols, which can facilitate the way in which processing equipment components are compared.

Considerations for E&L Analysis in Single-Use Systems

Updates to general chapters on compounding, <795> Nonsterile Preparations and <797> Sterile Preparation, include requirements for equipment, cleaning, personnel garb, labeling, and surface contamination testing.

USP Revises Drug Compounding Chapters

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

A possible change in leadership on Capitol Hill has aggravated fears of political push-back on FDA regulation and approval of contraceptives and other medications.

FDA Embroiled in Reproductive Rights Debate

AstraZeneca’s Imjudo (tremelimumab) was approved by FDA in combination with Imfinzi (durvalumab) for treating unresectable liver cancer.

FDA Approves AstraZeneca’s Imjudo for Combination Liver Cancer Treatment

An advisory committee’s vote to remove Makena from the market illustrates how difficult it is for regulators to ensure that such drugs document safety and effectiveness in a timely manner.

Pressure Mounts for FDA to Reform Accelerated Approval Program

South Africa’s vaccine regulator has reached new WHO level to ensure safety, quality, and effectiveness.

WHO Ranks South Africa’s Vaccine Regulatory System at a Functional Level of Maturity

The agency has recommended approval of Comirnaty and Spikevax for children from six months of age.

EMA Extends Use of COVID-19 Vaccines to Children

The agency has recommended authorization of the Spikevax COVID-19 vaccine that targets the Omicron variants BA.4 and BA.5.

Quality Systems