Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. The Agenda is typically updated twice per year, and it was last released in early January 2023.

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DrugBank

AUGUST 9, 2024

This high attrition rate directly results from the scientific and regulatory hurdles that drug candidates must overcome. The Investment Landscape Despite these challenges, the potential rewards for successful drug development are substantial. reported in 2021.

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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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FDA Law Blog: Drug Discovery

DECEMBER 20, 2023

Then, in early 2023, CDER and CBER started a slow phase-in of in-person meetings in a hybrid format, with some attendees present only virtually. At first, this option was only available for Type A meetings, Biosimilar Product Development (BPD) Type 1 sessions, and Type X meetings.

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Drug Target Review

SEPTEMBER 10, 2024

The current landscape of protein drug development is characterised by accelerated timelines where new drugs are approved in months rather than years. Hence, in many cases an earlier IND may be prevented by the timely provision of representative Drug Substance (DS) to execute such toxicology studies.

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FDA Law Blog: Biosimilars

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

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Vial

MARCH 1, 2024

By geographical region, the global CRO services market in 2023 was dominated by North America. Growth factors for this market included the growing size of the pharmaceutical industry, the increasing number of clinical trials , substantial funds dedicated to pharma and biotech R&D, and the growing biosimilars and generics market.

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DrugBank

OCTOBER 4, 2024

The IP surrounding Trodelvy , including patents covering the drug's composition, manufacturing process, and clinical use, was a significant valuation component. The high costs associated with bringing a new drug to market, estimated to be over $2.6

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Vial

APRIL 10, 2024

The increasing costs associated with in-house drug development have prompted biotech and pharmaceutical companies to increasingly outsource to contract research organization s (CROs) for assistance. The company reported a revenue of $11,116 million for the first nine months of 2023, marking a 4.2%

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PPD

JUNE 20, 2023

Prior analyses indicate that recessions can affect drug demand for myriad reasons, including lower utilization of patented biologics and branded drugs, as well as an uptick in utilization of biosimilars and generics. The drug development industry is undoubtedly in a season of change.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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Agency IQ

AUGUST 2, 2024

Letter Program Tag Commitment Due Date MDUFA International Harmonization Commencing with FY 2024, publish an annual assessment of the international harmonization activities described the strategic plan due by the end of FY 2023. use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

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FDA Law Blog: Biosimilars

OCTOBER 10, 2023

Beitz served in leadership positions in FDA’s Center for Drug Evaluation and Research for nearly three decades. She is an oncologist/hematologist and at the time she retired from FDA on July 29, 2023, she was the Director of the CDER Office of Immunology and Inflammation (OII) in the Office of New Drugs (OND).

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Agency IQ

JUNE 9, 2023

Here, we’re starting some deeper analysis of aspects of the proposal package with a look at the impact of orphan drug provisions, seeing what impact the new provisions and the surrounding uncertainty might have on innovation. Other orphan drugs, which, by definition, address an unmet medical need, “only” receive 9 years of market exclusivity.

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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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Agency IQ

JULY 8, 2024

BY SEBASTIAN GODOY, MPH , KIRSTEN MESSMER, PHD, RAC , COREY JASEPH, MS, RAC , KARI OAKES | OCT 25, 2023 5:20 PM CDT | UPDATED JUL 1, 2024 8:08 AM CDT What we expect to be talking about in July Regulators of all sizes – from the EMA to national competent authorities – will be busy managing a variety of meetings and trainings.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

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Agency IQ

FEBRUARY 12, 2024

In total, since August 2023, there have been 34 new guidances added to the agenda, 58 that have been carried over to the new calendar year, and 28 which were removed (most—but not all—of which were published since the last guidance agenda update). This week, CDER published its guidance agenda for 2024.

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Agency IQ

FEBRUARY 15, 2024

We’ve identified a total of 166 guidance documents that are under active development, and have the key details for you below. In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area.

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FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. is the largest dedicated food and drug law firm in the country.

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The Premier Consulting Blog

APRIL 25, 2023

President Biden of the United States (US) has recently signed into law the Fiscal Year 2023 Omnibus Appropriations Bill, which included the FDA Modernization Act 2.0. This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act, which applies to biosimilars.

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FDA Law Blog: Biosimilars

MARCH 13, 2024

10,544,220 (October 24, 2023) Pursuant to 37 C.F.R. the marketing applicant before the Food and Drug Administration to support the application for patent term extension of U.S. 10,544,220 (October 24, 2023) Pursuant to 37 C.F.R. 10,968,453 (November 29, 2023) Pursuant to 37 C.F.R. 10,544,220 (the ‘220 patent). Appendix D.

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FDA Law Blog: Drug Discovery

NOVEMBER 9, 2022

On September 30, 2022, President Biden signed into law the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023 , Division F of which is titled the “FDA User Fee Reauthorization Act of 2022” (“FUFRA”).

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Agency IQ

JULY 28, 2023

Everything the FDA is planning to do in Q3 2023 The third quarter of the 2023 calendar year is shaping up to be one of the busiest periods of regulatory policymaking at the FDA in at least the last decade. Notably, one aspect of its transition plan will come into effect on August 9, 2023.

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