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Pharmaceutical industry: 2023 in retrospect

European Pharmaceutical Review

JANUARY 29, 2024

During 2023, there were five revisions to the European Medicines Agency ’s (EMA’s) Questions and Answers (Q&As) for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products. These changes are summarised in Table 1.

FDA 96
FDA Vaccines Compounding 96
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2023 ISPE Aseptic Conference Regulatory Panel

ISPE

SEPTEMBER 8, 2023

Attendees were invited to submit questions to the FDA representatives. This article offers highlights from the discussion. A highlight of the session was the mutual praise from industry and regulators on how well the two parties worked together during the pandemic to bring vaccines and drugs to the patients in record time.

FDA 52
FDA Vaccines Documentation 52
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