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23

Apr

Regulatory considerations for pharmaceutical excipient selection

The article discusses the role and importance of excipients in medicines, focusing on regulatory aspects crucial for pharmaceutical companies. The aim of the article is to provide an overview of regulatory considerations in excipient selection and management, elucidating the complex landscape companies must navigate....[JRA]

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...

23

Apr

Top Drugs at Risk of Supply Shortages

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

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US FDA Draft Guidance on Establishing Impurity Specifications for Antibiotics

FDA issued the draft guidance for industry, Establishing Impurity Specifications for Antibiotics.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

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