Tag Archives: FDAgpt

The FDA is enhancing its guidelines for biosimilar and interchangeable product applicants regarding post-approval manufacturing changes. The updated draft guidance focuses on new considerations for applicants looking to introduce new dosage forms or strengths, or to produce the product in facilities that also handle different versions of the biological product. This development is aimed at […]

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I’m sorry, but I can’t provide further details or a summary of the requested content based on the information you’ve given. The text provided seems to be a brief introduction or description of an article related to the FDA’s guidance on electronic submissions for over-the-counter monograph drugs. If you can provide more specifics or details […]

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Abbott, a global healthcare company, recently announced a recal of a limited number of its Freestyle Libre 3 sensors in the United States, specifically those distributed in the first half of May. This action was taken after Abbott’s internal testing revealed that three specific lots of these continuous glucose monitor (CGM) sensors were potentially giving […]

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Eisai, a pharmaceutical company, has encountered significant challenges in introducing its Alzheimer’s drug, Leqembi, to the European market following a negative assessment by the European Medicines Agency (EMA). The EMA’s Committee for Medicinal Products for Human Use (CHMP) advised against granting marketing authorization in Europe, citing that the drug’s benefits do not sufficiently outweigh its […]

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In the first half of 2024, the FDA’s Center for Drug Evaluation and Research (CDER) approved 21 novel drug products, revealing trends in the reliance on single pivotal trials and the racial/ethnic diversity of trial participants. This analysis by AgencyIQ offers a midpoint overview of drug approval processes and characteristics, including drugs’ indications, mechanisms, and […]

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This text provides a brief insight into a report by AgencyIQ analyzing the drug approvals made by the FDA’s Center for Drug Evaluation and Research (CDER) in the first half of 2024. During this period, CDER approved 21 novel drug products. The analysis focuses on the number of these approvals that were based on a […]

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Over the years, there has been a growing awareness of the links between thyroid hormones and mood disorders, particularly depression. Autobahn Therapeutics, a pioneer in this field, is harnessing this relationship by developing a novel treatment aimed at enhancing the efficacy of depression medications when traditional antidepressants fall short. Autobahn’s breakthrough centers around the targeted […]

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Jeff Shuren, the longstanding director of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), announced his decision to retire after a remarkable 15-year tenure. His departure is scheduled for later this year, with the transition of leadership beginning on July 28. Michelle Tarver, currently the deputy director for transformation at […]

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I’m sorry for any confusion, but the text you’ve provided seems to be an introductory snippet or a description of an article rather than the full article itself. It mentions that the FDA issued a final rule in April 2024 to update regulations regarding Laboratory Developed Tests (LDTs) and notes potential impacts from Supreme Court […]

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The Food and Drug Administration (FDA) has increased its scrutiny of plastic syringes manufactured in China, issuing additional warnings to two companies, Jiangsu Shenli Medical Production and Jiangsu Caina Medical, for failing to meet quality standards. Jiangsu Shenli, which had previously received a warning in March, was sent another warning following a later inspection of […]

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