FDA Law Blog: Biosimilars

AUGUST 23, 2023

FDA has made good progress on these initial goals, providing updates on the first four on the Digital Health Technologies (DHTs) for Drug Development website. Earlier this year, FDA published the Framework for the Use of Digital Health Technologies in Drug and Biological Product Development (DHT Framework).

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The Premier Consulting Blog

OCTOBER 1, 2023

It is the sixth reauthorization of PDUFA that provides the FDA with necessary resources and includes provisions to increase the efficiency of the drug development process. PDUFA VII will be in effect from fiscal year 2023 through fiscal year 2027.

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Vial

FEBRUARY 29, 2024

Contract research organizations (CROs) are an integral partner of the drug development process, as they play a pivotal role supporting clinical trial conduct for pharmaceutical, biotechnology, and medical device sponsor companies. A rise of clinical trial outsourcing due to cost management, globalization, and digitalization.

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Perficient: Drug Development

AUGUST 12, 2023

The AI market is projected to reach $407B by 2027, which is substantial growth from its $86.9B This is what everyone is talking about in the market, and I couldn’t be more excited to learn not just about Salesforce AI capabilities, but how we can understand and trust AI more effectively. in revenue in 2022.

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Perficient: Drug Development

DECEMBER 27, 2023

The effective date of the new rule is April 1, 2024, with key provisions taking effect on January 1, 2026, and January 1, 2027. Banks Additionally, the recent rule by the OCC, the Federal Reserve, and the FDIC strengthens and modernizes Community Reinvestment Act (CRA) regulations.

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Agency IQ

MAY 17, 2024

How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. The generic drug user fee program is currently on its third iteration (i.e.,

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Agency IQ

NOVEMBER 3, 2023

October 1, 2027) in order to align with the next iteration of the device user fee program, the QS compliance requirement for LDTs could theoretically be in place by FY2027. The system as proposed could have compounding implications across the life sciences industry, including for drug development.

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