FDA Law Blog

MARCH 5, 2023

Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. FDA may deny a PSG if the applicant’s bioequivalence testing started after the PSG publication.

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The role of pharmacometrics for biosimilars is no less significant than for biologics.

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Camargo

JULY 8, 2021

Researchers at the Broad Center of Regenerative Medicine and Stem Cell Research at UCLA have observed that MAOIs might help the immune system attack cancer. Although still available as generics, for the most part they have been replaced by newer drugs with fewer side effects.

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pharmaphorum

OCTOBER 21, 2020

Zosano Pharma has been hit by an FDA rejection of its marketing application for migraine drug Qtrypta, asking for new bioequivalence data. Qtrypta is Zosano’s lead product candidate, but the company is also working on a follow-up in phase 2/3 for cluster headache.

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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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pharmaphorum

JANUARY 17, 2022

The case was brought by the US Federal Trade Commission (FTC) and US states New York, California, Illinois, North Carolina, Ohio, Pennsylvania and Virginia, for Shkreli’s actions that blocked any competition with its key medicine to preserve monopoly profits.

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The Pharma Data

AUGUST 5, 2020

The US Food and Drug Administration and European Medicines Agency are currently reviewing ofatumumab for the treatment of relapsing forms of multiple sclerosis (RMS) in adults . ” These data were published in the August 6, 2020 issue of The New England Journal of Medicine. J Neurol Sci. 2003;206(2):165–71.

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Druggist

MARCH 25, 2021

New generic drugs are usually cheaper than original patent medicine, therefore switch in prescribing follows in the NHS. There are other ways of getting medicines on private prescriptions. . As with other drugs, some patients may believe that branded medicine is better than generic medication. 2009). .

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Pharmaceutical Technology

OCTOBER 28, 2022

It aims to ensure the quality of medicines by employing statistical, analytical, and risk-management methodology in the design, development, and manufacturing processes of medicines. Biosimilars are biologic medical products that almost exactly replicate products already being manufactured by other companies.

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World of DTC Marketing

FEBRUARY 21, 2022

Pfizer and Merck have chosen to designate a select few generic manufacturers to produce cheaper versions of their drugs through the Medicines Patent Pool (MPP). Experts across the board are predicting demand for antiviral drugs will rapidly outpace supply. At this point, one must wonder why the U.S. About those copay cards.

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The Pharma Data

SEPTEMBER 26, 2021

The CHMP’s positive opinion will now be mentioned the ecu Commission (EC), which grants marketing authorizations for medicines in Europe. “We Today’s CHMP opinion may be a crucial breakthrough in providing an oral therapeutic option that’s easy to integrate into a patient’s lifestyle , which helps with ongoing care management.”.

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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 MS, the coronavirus and vaccines – updated global advice. Available at: [link] Accessed: January 2021.

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The Pharma Data

AUGUST 9, 2021

Food and Drug Administration (FDA) approved SKYRIZI 150 mg in April based on data from three clinical trials showing the single-dose SKYRIZI 150 mg injection was bioequivalent, working the same as two injections of SKYRIZI 75 mg per dose with a consistent efficacy and safety profile. .” The U.S. are breastfeeding or plan to breastfeed.

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Worldwide Clinical Trials

MAY 30, 2024

was withdrawn, rendering it unapproved for patient use, based on negative review comments by the Committee for Medicinal Products for Human Use. The treatment difference was 2.49 (0.99 – 3.98) p=0.0013. The MAA file in the E.U. This is administered according to the same treatment regimen as for the IV infusion.

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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.” Association for Accessible Medicines.

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The Pharma Data

MAY 3, 2021

How the FDA’s ‘master plan’ will affect NIH funding for digital medicine projects ( STAT ). 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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