FDA Law Blog

JUNE 10, 2024

As a reminder, the BIMO program oversees a wide range of activities related to FDA-regulated research, including human and animal studies, and covers the full gamut of FDA centers (CDER, CBER, CDRH, CFSAN, CTP, and CVM). Maintain accurate and detailed records of all research activities, including raw data, test results, and correspondence.

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The Pharma Data

APRIL 11, 2023

Dose proportionality and bioequivalence studies demonstrate once-daily AUSTEDO XR is therapeutically equivalent to twice-daily AUSTEDO ® (deutetrabenazine) tablets The U.S. Bioequivalence and relative bioavailability were established between the once-daily and twice-daily tablet formulations, with no new safety findings emerging.

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The Pharma Data

FEBRUARY 1, 2021

The FDA’s approval of the IM administration for Plegridy is based on data evaluating bioequivalence and adverse reactions associated with IM administration compared to SC administration in healthy volunteers. percent vs. 32.1 Available at: [link] Accessed: January 2021. 3 Zhao Y, et al. Source: Biogen.

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Delveinsight

FEBRUARY 5, 2021

The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. Rather, the bioequivalence studies were performed using the 150 mg strength; and the data was extrapolated to the higher dose. Quitting smoking is an arduous, exhausting process. However, it is possible.

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Marketing FDA Approval Branding Production 52

The Pharma Data

SEPTEMBER 26, 2021

Head of Research and Development at Biogen. “We anticipate to advancing Biogen’s portfolio and continuing to figure with the MS community to deal with critical treatment challenges, including people who affect persistence and adherence to medication for this chronic and life-long disease,” said Alfred Sandrock, Jr.,

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The Pharma Data

DECEMBER 17, 2020

TLC’s Ampholipad (amphotericin B liposome for injection) for the treatment of systemic fungal infections, is the only complex generic drug which has shown bioequivalence to Gilead’s AmBisome ® in all three forms, proving its sameness as the originator. About TLC.

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The Pharma Data

AUGUST 5, 2020

In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Onset of B-cell depletion with subcutaneous administration of ofatumumab in relapsing multiple sclerosis: results from the APLIOS bioequivalence study. J Neurol Sci. 2003;206(2):165–71.

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Druggist

MARCH 25, 2021

Generic medicines must go through bioequivalence studies to show that generic medicine produces the same amount of active drug in the body. Bioequivalent studies may involve humans or animals (EMA, 2012). . An extensive research study looked at bioequivalent information from 2070 studies that took place over 12 years.

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Branding Bioequivalency Pharmacy Generic Drugs 98

FDA Law Blog

JANUARY 23, 2023

This subsection requires sponsors of any phase 3 or other pivotal drug study (other than bioavailability or bioequivalence studies) to submit diversity action plans by the time they submit the study protocol. Clinical Trial Diversity Under FDORA FDORA adds subsection 505(z) to the Food, Drug, and Cosmetic Act (FDC Act).

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Trials Clinical Trials Clinical Trials Drugs 59

FDA Law Blog

JULY 9, 2024

For drugs, the relevant studies are any Phase 3 study or, as appropriate, another pivotal study of a new drug (other than bioavailability or bioequivalence studies). . § 355(z)(3) and 21 U.S.C. 360j(g)(9)(A)). For devices, the requirement is a bit more nuanced. providing language assistance); Reducing participant burden (e.g.,

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Drug Patent Watch

JANUARY 22, 2025

The Science Behind Generic Drug Bioequivalence: Separating Fact from Fiction As a healthcare professional or someone simply looking to stay informed, you've likely heard the term "bioequivalence" thrown around when it comes to generic drugs. But what does it really mean, and how does it impact the medications we take?

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Bioequivalency Generic Drugs Drugs Branding 81

Drug Patent Watch

JANUARY 7, 2025

They’re designed to be bioequivalent, meaning they have the same dosage, strength, route of administration, quality, and intended use as the original brand-name drug. For example, instead of saying “bioequivalent,” you might say “works the same way in the body.” What Are Generic Drugs?

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The Pharma Data

MAY 3, 2021

Mental health/psychedelic drugs: mushrooming investor interest fuels research ( FT ). Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ). Korea To Toughen Co-Bioequivalence Study System Amid Generic Quality Issue ( Pink Sheet ). Medtech.

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