h-header

news

News dal mondo

27

Apr

US QMM: Participants scored well on commitment to quality, lower on advanced manufacturing

Pharmaceutical companies participating in the US Food and Drug Administration (FDA) Quality Maturity Pilot (QMM) program generally received high scores for their commitment to quality and employee engagement, but scored lower in areas related to advanced pharmaceutical quality and technical excellence.

Eric Twum, a regulatory specialist for the Division of Quality II in the Office of Quality Surveillance (OQS) within the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER), shared these insights on the QMM pilot at the Generic Drugs Forum held online and in White Oak, MD, on 22 April....[RAPS]

23

Apr

Top Drugs at Risk of Supply Shortages

Nearly half of 100 vulnerable medicines have at least one key starting material sourced exclusively...

23

Apr

Regulatory considerations for pharmaceutical excipient selection

The article discusses the role and importance of excipients in medicines, focusing on regulatory aspects...

21

Apr

TGA clarifies therapeutic goods are unaffected by chemical production and import ban

TGA has clarified the impact of Australia’s industrial chemicals standards on medicines, medical...

20

Apr

US FDA Draft Guidance on Establishing Impurity Specifications for Antibiotics

FDA issued the draft guidance for industry, Establishing Impurity Specifications for Antibiotics. This...

slider-banner

h-footer