Drug Target Review

AUGUST 7, 2024

The preclinical role of often-overlooked artwork During preclinical stages, labelling decisions can significantly impact clinical trials and eventual drug commercialisation. Packaging is typically the patient’s first interaction with a product, and it is critical for communicating safety and benefit-risk information.

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Drug Development Clinical Pharmacology Clinical Trials Packaging 59

The Premier Consulting Blog

NOVEMBER 4, 2023

The test methods need not be provided in the pre-IND meeting documentation; rather, it suffices to have a strategy in place to account for these drug substance-related impurities. The impact of the device on the drug product quality attributes and safety are suitable issues for discussion in the pre-IND meeting.

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Agency IQ

JULY 8, 2024

In early June, we’re expecting to see what the FDA will allow life sciences companies to do in this fight as it releases a new draft guidance document. In early June, we’re expecting to see what the FDA will allow life sciences companies to do in this fight as it releases a new draft guidance document. and the E.C.

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FDA Science Regulations Production 40

Agency IQ

MAY 3, 2024

FDA’s Diversity Action Plan guidance: The FDA’s hotly-anticipated revised draft guidance document is currently under review at the White House’s Office of Information and Regulatory Affairs (OIRA), and we anticipate that it will be published over the next two months.

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Agency IQ

OCTOBER 27, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published. FDA is also due to revise 24 other guidance documents at that time. AgencyIQ November 18 Shutdown (?)

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Agency IQ

FEBRUARY 23, 2024

The discussions in this workshop incorporated the content of a draft guidance document on the topic released by the FDA in 2023, as well as the information shared in another series of workshops co-hosted by the FDA and the American Society of Clinical Oncology (ASCO), which occurred in 2022 and 2023.

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Agency IQ

DECEMBER 1, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

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