FDA Law Blog: Biosimilars

MARCH 8, 2023

Test deployment for the changes listed above were deployed to eMDR on August 19, 2022 and will be deployed to production on March 17, 2023. This was deployed to pre-production on August 19, 2022 and implemented in eMDR and eSubmitter the same day.

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The Pharma Data

MAY 2, 2022

The companies expect to complete submission of the NDA for treatment of MDD in the second half of 2022; associated filing for postpartum depression anticipated in the first half of 2023. Sage Therapeutics, Inc. Nasdaq: SAGE) and Biogen Inc. Nasdaq: BIIB) initiated a rolling submission of a New Drug Application (NDA) to the U.S.

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Drug Target Review

SEPTEMBER 10, 2024

However, developing an accelerated IND application requires that good laboratory practice (GLP) toxicological data must be generated, collected, interpreted and integrated in the IND-enabling data package. 2022 Dec 8:10.1002/bit.28302 2023 Jan 13;379(6628):127-128 2 Tan KW, et al. Biotechnol Bioeng. 28302 3 Broly H, Souquet J, Beck A.

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FDA Law Blog: Biosimilars

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 Whether a firm used the 10-day call and/or an SIR, it should include any prior feedback from those interactions with FDA in the AI response and describe how and where in the AI response package the prior feedback was addressed.

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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

MARCH 1, 2024

Notably, shutdowns can be either total or partial – as noted above, there are 12 appropriations bills, and if a subset of those bills are passed then only those agencies and Departments without an appropriations package will shut down (partial shutdown). According to a FY 2022 report , the program had $13.1 The longest shutdown in U.S.

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Agency IQ

JULY 8, 2024

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED JUN 28, 2024 6:45 PM CDT What we expect to be talking about in July and August Chevron Shakeout : Just how soon will it take for companies to begin attacking FDA over the recent Loper Bright Supreme Court case overturning the Chevron Doctrine?

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The Pharma Data

AUGUST 3, 2021

Product sales increased 3% globally, driven by double digit volume growth across a number of our products including Prolia ® (denosumab), Repatha ® (evolocumab) and our biosimilar products MVASI ® (bevacizumab-awwb) and KANJINTI ® (trastuzumab-anns). AMGEVITA continued to be the most prescribed adalimumab biosimilar in Europe.

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Agency IQ

AUGUST 2, 2024

For example, the German medtech trade organization (BVMed) is hosting a webinar on September 9 to offer industry an overview of the upcoming launch of upcoming cybersecurity policy, European NIS-2 Directive ( EU 2022/2555 ) that aims to harmonize cybersecurity measures across the E.U

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Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI). The FDA recently concluded its work on a proposed rule focused on PMI.

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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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Agency IQ

OCTOBER 27, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events. November is packed with regulatory and industry meetings.

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Agency IQ

DECEMBER 1, 2023

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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Agency IQ

JULY 28, 2023

And following the reauthorizations of several of the FDA’s user fee programs in late 2022 – PDUFA, GDUFA, MDUFA and BsUFA – the FDA has an enormous amount of things it has committed to doing as of October 1, 2023. Therefore many of the FDA’s deadlines are tied to the start or end of the fiscal year.

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FDA Law Blog: Biosimilars

DECEMBER 14, 2023

In October 2022 President Biden asked the Secretary of HHS and the Attorney General to “initiate the administrative process to review expeditiously how marijuana is scheduled under federal law.” As explained more fully explained below, that impression would be partially correct, but partially incorrect.

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