FDA Law Blog: Biosimilars

SEPTEMBER 17, 2024

The Untitled Letter states that the TV ad misleadingly suggests that UBRELVY provides a greater benefit in treating migraines than what has been demonstrated in clinical trials, which, from a public health perspective, can mislead healthcare providers, patients, and caregivers.

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The Pharma Data

MAY 6, 2021

ENVI calls on the Commission to “revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU.”. . Denmark posts guidance on decentralizing clinical trials.

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FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

For these devices that do not have market authorization and are only used for remote data collection in a clinical investigation, if the sponsor conducts verification and validation activities consistent with the guidance to demonstrate the DHT is “fit-for-purpose,” FDA does not intend to assess sponsors’ compliance with design controls.

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Agency IQ

MAY 3, 2024

Two consultations on clinical trial considerations, one on advanced therapies and the other addressing non-inferiority and equivalence comparisons, are closing at the end of May. Parliament voted on the extension to the diagnostic regulation (IVDR) compliance deadlines in plenary this week. The pharma reform package remains in E.U.

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Agency IQ

MARCH 1, 2024

There are also some product-specific bioequivalence guidelines open for comment, along with concept papers proposing the development of materials on the topics of biosimilar development and non-inferiority comparisons in clinical trials. The file will head to the Parliament for a vote next. Device news is unsettled.

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FDA Law Blog: Biosimilars

JANUARY 15, 2024

FDA extended PMTA compliance deadlines for years so it could figure out appropriate application instructions and so that manufacturers could figure out how to comply. FDA said randomized clinical trials could be used, but so could observational studies with respect to cessation data.

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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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FDA Law Blog: Biosimilars

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

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Agency IQ

MARCH 29, 2024

medical device regulators are expected to pass some notable legislative amendments, which would extend the compliance deadlines of the IVD Regulation by risk class, allow a phased roll-out of EUDAMED, and also require manufacturers to notify stakeholders of any interruptions in device supply.

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Agency IQ

JUNE 2, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., These inspections will be routine surveillance rather than inspections as part of an approval application.

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Agency IQ

JULY 8, 2024

Device regulators have dropped important guidance recently , publishing guidance on alternative trial designs for orphan devices and updating how to carry out benefit-risk assessments on the use of toxic phthalates in medical devices. elections over, AgencyIQ is also anticipating the new European Parliament to start work again soon.

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Agency IQ

AUGUST 2, 2024

While the work on the pharma package will likely take quite some time, another deadline is coming up fast: the full transition of all clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation.

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Agency IQ

JUNE 29, 2023

6/27/2023 Notification FDORA, Section 3201 Within 180 days of the passage of FDORA, all biologics and biosimilars sponsors must submit a written notice to the FDA of all actively marketed products (i.e., These inspections will be routine surveillance rather than inspections as part of an approval application.

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Agency IQ

MAY 31, 2024

.: Hands-on training course Webinar/Seminar ( OPEN ) EMA 6/03/2024 6/03/2024 EUCOPE’s Life Science Lectures – Episode Five (Joint Clinical Assessments) Webinar/Seminar ( OPEN ) EUCOPE 6/04/2024 6/04/2024 EUDAMED, the pathway to compliance Webinar/Seminar ( OPEN ) Team Person Responsible for Regulatory Compliance (TEAM-PPRC) 6/04/2024 6/04/2024 News (..)

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market. That did not happen.

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The Pharma Data

MAY 15, 2023

The Sandoz Board of Directors will have 10 members in total and 3 sub-committees: a Science, Innovation & Development Committee, a Human Capital & ESG Committee and an Audit, Risk & Compliance Committee. He will be Chair of the Audit, Risk & Compliance Committee of Sandoz.

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Agency IQ

SEPTEMBER 29, 2023

Title Type Comments Close Classification Categories for Certain Supplements Under BsUFA III Guidance October 10 Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Biosimilar User Fee Act Products Guidance October 10 QTc Information in Human Prescription Drug and Biological Product Labeling Guidance October 10 Postmarketing (..)

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Agency IQ

OCTOBER 27, 2023

Webinar/ Seminar ( OPEN ) Coordinating Research and Evidence for Medical Devices (CORE-MD) 11/6/2023 11/7/2023 ENVI Committee Meetings in 2023 Committee Meeting ( OPEN ) European Parliament committee on the environment, public health and food safety (ENVI) 11/6/2023 11/8/2023 6th European Training Course on Quality Management for Blood Establishments (..)

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The Pharma Data

SEPTEMBER 16, 2020

About CodeBreaK The CodeBreaK clinical trial program for Amgen’s investigational drug sotorasib is designed to treat patients with multiple KRAS G12C -mutant solid tumors and address the longstanding unmet medical need for these cancers. The Phase 2 CRC trial is expected to have a data readout in early 2021.

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The Pharma Data

JULY 27, 2021

The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected.

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FDA Law Blog: Biosimilars

AUGUST 16, 2023

However, in the testing strategy from the trial, the raw p-value of each hypothesis test was compared to the corresponding critical value to determine whether the test was statistically significant. OPDP states that a p-value is generally understood to indicate statistical significance if it is less than 0.05.

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The Pharma Data

SEPTEMBER 20, 2020

About CodeBreaK The CodeBreaK clinical trial program for Amgen ‘s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. The Phase 2 CRC trial is expected to have a data readout in 2021.

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Agency IQ

OCTOBER 27, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .”

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The Pharma Data

SEPTEMBER 17, 2020

If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities.

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The Pharma Data

OCTOBER 29, 2020

In the third quarter, we further progressed our LEAD-EXPAND-DIVERSIFY strategy with multiple regulatory approvals, the initiation of new Phase 3 trials and the integration of the Portola team,” said Ludwig Hantson , Ph.D., Chief Executive Officer of Alexion. ” Third Quarter 2020 Financial Highlights.

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The Pharma Data

DECEMBER 21, 2020

21, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and AstraZeneca today announced the SOURCE trial did not meet the primary endpoint of a statistically significant reduction in the daily oral corticosteroid (OCS) dose, without loss of asthma control, with tezepelumab compared to placebo. THOUSAND OAKS, Calif. ,

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The Pharma Data

NOVEMBER 9, 2020

Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.

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The Pharma Data

APRIL 27, 2021

reflecting increased competition partially offset by demand growth partly related to clinical trial supply and price upside in Europe. reflecting lower treatment compliance during the COVID-19 pandemic. The second pivotal trial to study itepekimab in chronic obstructive pulmonary disease (COPD) (AERIFY-2) enrolled its first patient.

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The Pharma Data

AUGUST 3, 2021

The company announced positive top-line results from the SURPASS-4 Phase 3 clinical trial of tirzepatide in adults with type 2 diabetes, evaluating A1C and body weight reductions from baseline. The trial compared tirzepatide to insulin glargine in adults with type 2 diabetes and increased cardiovascular risk. Revenue outside the U.S.

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Agency IQ

FEBRUARY 12, 2024

A new real-world evidence guidance on the list is meant to address the integration of randomized controlled trials for drug and biological products into routine clinical practice. This is a topic that the agency has been keenly aware of for years, but it’s not clear from the title if it will refer to how the FDA will use A.I.

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The Pharma Data

AUGUST 13, 2020

If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities.

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The Pharma Data

AUGUST 13, 2020

If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities.

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Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

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Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. ” These include the use of expansion cohorts, concurrent trial conduct, and other designs. .” Comments on the proposal closed on July 19.

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Agency IQ

SEPTEMBER 1, 2023

When the ECDRP is invoked, the MHRA will ensure a product’s compliance with applicable regulatory requirements, but will generally perform a less detailed review of the application, relying in part on the decision taken by the EC. The procedure is available for E.U. Major objections may revert the application to the Recognition B procedure.

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