Agency IQ

OCTOBER 20, 2023

Biosimilars are biological products that are highly similar (but not identical) to a previously approved biological product and have “no clinically meaningful” differences relative to the original reference product. Hence, they are “similar” – not the same – as the reference product.

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Agency IQ

FEBRUARY 2, 2024

Legal Deadline March 7 Considerations for the Development of CAR T Cell Products FDA CBER March 15 Patient Listening Session: Patients with ADHD FDA March 22 Patient Listening Session: Patients with ADHD FDA March 25 Deadline to participate in the Quality Management Maturity Program Pilot. This is what OIRA is currently reviewing.

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Agency IQ

JULY 8, 2024

FDA Regulations and guidance under OIRA review as of July The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.

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Metabolite Tales Blog

JULY 5, 2023

Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Previously natural products have provided the source of up to 90% of macrocyclic drugs, not surprising given that 20% of natural product derived ring systems are macrocyclic [2]. Garcia Jimenez et al.,

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Metabolite Tales Blog

JULY 5, 2023

Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Previously natural products have provided the source of 80-90% of macrocyclic drugs, not surprising given that 20% of natural product derived ring systems are macrocyclic. [2] Garcia Jimenez et al.,

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The Pharma Data

OCTOBER 1, 2021

Deucravacitinib demonstrated efficacy no matter baseline characteristics, including weight , disease severity and former treatment with biologic or non-biologic therapies. Psoriasis may be a widely prevalent, chronic, systemic immune-mediated disease that substantially impairs patients’ physical health, quality of life and work productivity.

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Agency IQ

SEPTEMBER 15, 2023

The monographs functioned as rule books for specific classes of OTC drugs, describing active ingredients, doses, indications, labeling and tests requires for covered OTC products to be generally recognized as safe and effective (GRASE). The FDA maintains a webpage with the full rulemaking history for OTC nasal decongestant drug products.

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The Pharma Data

NOVEMBER 9, 2020

He is also a current member of the Health Canada Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology and the Scientific Advisory Panel on Opioid Analgesic Abuse. Psilocybin has recently been designated twice as a “breakthrough therapy” by the U.S.

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Agency IQ

MARCH 1, 2024

As it happens, EtO is essential for the sterilization of many medical devices, and the EtO final rule is expected to kick off a frantic period for regulators as they try to authorize substitute methods for device sterilization and ensure device products do not go into shortage. This is what OIRA is currently reviewing.

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Agency IQ

JUNE 2, 2023

The proposed rule would require clear and concisely written prescription drug product information presented in a consistent and easily understood format to help patients use their prescription drug products safely and effectively.

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FDA Law Blog: Drug Discovery

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g.,

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Eye on FDA

AUGUST 4, 2021

FDA maintains a vast network of outside advisors to provide input and counsel to the agency related to decisions on policy as well as product approvals. Breakthrough Therapy is a pathway designed to expedite the consideration of a new drug for a serious condition where the drug may bring significant change to the treatment landscape.

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The Premier Consulting Blog

JUNE 18, 2023

One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases. As a direct consequence, in silico methods in human clinical trials are emerging as an important new paradigm in the development of medical therapies – particularly useful for rare diseases.

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Agency IQ

OCTOBER 6, 2023

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics).

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Agency IQ

SEPTEMBER 29, 2023

An avalanche of new legislation: Speaking of Congress, the House and Senate are back in session as of mid-September and we have already noticed a lot of legislative interest in the FDA – probably about two dozen bills related to drug shortages, generic drug competition, supply chain security, opioids, medical device recalls and orphan drug products.

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Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Administrative, Procedural Enforcement Policy for In Vitro Diagnostic Product for Immediate Response to an Emerging Outbreak of an Infectious Biological Agent Prior to a Declaration under Section 564 CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority A List. Called for under MDUFA. Priority A List.

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Agency IQ

FEBRUARY 23, 2024

BY CHELSEY MCINTYRE, PHARMD , KARI OAKES | FEB 21, 2024 7:48 PM CST Background: Dose-finding in oncology Traditionally, early development of oncology products has focused on identifying the maximum tolerated dose (MTD) of an investigational product.

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Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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Alta Sciences

MAY 15, 2023

Integrated Clinical Sites Accelerate Timelines Well-suited and qualified clinical pharmacology units (CPUs) for early phase trials are getting more expensive to run due to the growing complexity of required clinical procedures, and the precision around participants to be recruited.

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Agency IQ

DECEMBER 11, 2023

BY RACHEL COE, MSC | DEC 6, 2023 5:27 PM EST The push and pull: Trends in oncology After the creation of the Accelerated Approval Pathway, several policies in the early 2000s were put in place with the goal of getting cancer products to patients faster. OCE has also been busy this year.

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The Pharma Data

FEBRUARY 8, 2021

1 Quality of life was comparable between treatment arms per Functional Assessment of Cancer Therapy–Prostate (FACT-P Total). v] ERLEADA ® is being studied in five Phase 3 clinical trials. . ‡ Thyroid replacement therapy, when clinically indicated, should be initiated or dose-adjusted. percent in the control arm.

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Agency IQ

DECEMBER 1, 2023

This is what OIRA is currently reviewing. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

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The Pharma Data

OCTOBER 15, 2020

The award honors McHutchison’s work in developing life-changing and curative therapies for patients with the hepatitis C virus. Axovant – Kristin Vuori was named to the board of directors at Axovant Gene Therapies Ltd. Trevi Therapeutics – Shashank Rohatagi was named vice president of Pharmacology and Clinical Phrarmacokinetics.

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The Anticancer Fund

JUNE 7, 2022

However, patients treated with subsequent therapies, including rechallenge with previous treatments some showed very encouraging responses - intriguingly suggesting the combination treatment may work to reverse drug resistance in this population with few other options.

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