FDA Law Blog: Biosimilars

SEPTEMBER 18, 2024

Under FDA’s interpretation, it is impossible to determine whether there is a non-public IND prior to starting work on developing an ingredient as a dietary supplement. However, FDA’s interpretation creates that exact risk for a dietary supplement manufacturer who invests in development of a dietary supplement.

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Drug Discovery World

MARCH 29, 2023

According to the Wellcome Trust 5 , it can take between 10 and 15 years and over $1billion to develop a new antibiotic, so systems such as this aim to provide incentive to drug developers. At the same time, we have to find and implement actions that improve the significant variance in accessing new medicines across Europe.

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DrugBank

OCTOBER 4, 2024

This involves assessing the strength and breadth of patents, evaluating the potential for future patent challenges, and analyzing the value derived from licensing agreements and royalty streams. The high costs associated with bringing a new drug to market, estimated to be over $2.6

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Agency IQ

AUGUST 2, 2024

By Alexander Gaffney, MS, RAC | Aug 31, 2022 6:50 PM CDT | Updated Jul 29, 2024 9:45 PM CDT What we expect to be talking about in August and September The end of the fiscal year (and a budget showdown or shutdown) : The last day of the government’s fiscal year is September 30, which will mark an especially busy period for the FDA.

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Agency IQ

JUNE 2, 2023

In 2022 and 2021, the Spring Unified Agenda was released in early/mid June. The proposed rule would require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

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Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Biosimilars

MARCH 13, 2024

The PTE application states “[u]nder the terms of the AMENDED AND RESTATED DEVELOPMENT AND COMMERCIALIZATION LICENSE AGREEMENT between Pfizer Inc. exclusively licensed U.S. However, an exclusive license is not an authorization to rely on the activities of the marketing applicant for a PTE application. and OPKO Ireland Ltd.

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