Agency IQ

JUNE 9, 2023

The low prevalence of individual orphan diseases poses challenges for building a scientific knowledge base and poses hurdles for clinical trial conduct, though collectively the diseases have a big impact. population) is considered heterogenous due to the developing physiological characteristics which makes clinical trial conduct challenging.

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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. The pharma reform package remains in E.U. leaders’ eyesight as the Parliament winds down ahead of its June elections.

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Agency IQ

DECEMBER 1, 2023

Positive *Biosimilar **Generic Notable comment periods closing in December Below are various deadlines regarding E.U. Positive January 2023 Azacitidine Kabi (azacitidine)** Fresenius Kabi Deutschland GmbH Positive January 2023 Krazati (adagrasib) Mirati Therapeutics B.V.

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Agency IQ

OCTOBER 6, 2023

For example, these products face a much more arduous path for development of biosimilar or interchangeable products than that of generics for small molecules. As AgencyIQ has previously discussed , developing biosimilars is an expensive process. The trend of incorporating clinical trial diversity into PMRs continued in FY 2023.

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Agency IQ

MARCH 29, 2024

regulatory framework Webinar/ Seminar ( OPEN ) EMA 4/17/2024 4/17/2024 CEP 2.0:

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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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Vial

APRIL 24, 2024

Introduction In a landscape where many contract research organizations (CROs) are available, Vial is breaking through with its promise to deliver on its vision to empower scientists to cure all human diseases by reimagining clinical trials. Digital therapeutics is not explicitly listed as a therapeutic area of expertise for Syneos Health.

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Clinical Trials Trials Biosimilars Disease 52

Agency IQ

OCTOBER 20, 2023

BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions This week, FDA and its grantees briefed stakeholders on the status of research projects funded through the Biosimilar User Fee Act (BSUFA III) Regulatory Science Pilot Program. Developing biosimilars is an extensive and expensive process.

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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

SEPTEMBER 22, 2023

Interestingly, that commitment can be found in the letter’s section on commitments related to digital health technologies (DHTs) , or digital products that are used to “obtain clinical trial data directly from patients,” a new category of tools that the FDA has defined only after the PDURS framework was initially released.

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FDA Law Blog: Biosimilars

OCTOBER 24, 2023

These guidances focused on the types of scientific publications (journal articles, reference texts, and in 2014, clinical practice guidelines) and necessary accompanying information that firms could proactively provide in a manner that would not, on its own, constitute evidence of a new intended use.

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Agency IQ

MAY 31, 2024

Conference ( OPEN ) European Federation of Pharmaceutical Industries and Associations (EFPIA) 6/04/2024 6/05/2024 Third listen-and-learn focus group meeting of the Quality Innovation Group Webinar/Seminar ( OPEN ) EMA Quality Innovation Group (QIG) 6/05/2024 6/05/2024 Procurement Working Party Committee Meeting ( CLOSED ) British In Vitro Diagnostics (..)

Regulations 40

Regulations Production Compliance Pharmaceuticals 40

Vial

MARCH 1, 2024

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. By geographical region, the global CRO services market in 2023 was dominated by North America.

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Clinical Trials Clinical Research Trials Laboratories 52

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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Agency IQ

JUNE 29, 2023

e.g., “ In a clinical trial, Drug X reduced the risk of stroke by 50%. By way of example , if a company claims that a trial showed that 68% of patients treated with Drug X experienced a reduction in blood glucose levels, they should also note the reduction experienced by patients treated with the standard of care or placebo.

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FDA Drugs Regulations Production 40

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. Go deeper with our experts on rebadging advantages and best practices in this Applied Clinical Trials article.

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Clinical Trials Drug Development Trials Clinical Research 52

Agency IQ

JULY 13, 2023

BY ALEXANDER GAFFNEY, MS, RAC JUL 10, 2023 10:02 AM CDT As of FY2023, the FDA has five user fee programs applicable to its life sciences portfolio: PDUFA (for non-generic prescription drugs and certain biologics), MDUFA (for medical devices), GDUFA (for generics), BsUFA (for biosimilars), and OMUFA (for over-the-counter monograph products).

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Agency IQ

AUGUST 2, 2024

September 30, 2024 Upcoming (or overdue) legislative requirements due as of August and September Congress often asks the FDA to release or hold guidance documents, regulation, reports, meetings, hearings or pilot programs as of specific dates.

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Agency IQ

MAY 3, 2024

AgencyIQ also in attendance.

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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

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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FDA Science Regulations Production 40

The Pharma Data

AUGUST 13, 2020

We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products.

Production 52

Production Government Regulations Marketing 52

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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FDA Science Regulations Production 40

Agency IQ

JULY 8, 2024

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

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FDA Science Regulations Production 40

The Pharma Data

AUGUST 13, 2020

We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products.

Production 52

Production Government Marketing Regulations 52

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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Agency IQ

FEBRUARY 15, 2024

We have tried to sort guidance documents by topic area.

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FDA Science Biosimilars Clinical Trials 40

Agency IQ

SEPTEMBER 1, 2023

Products eligible to qualify for the IRP include chemical and biological new or known active substances ( Regulation 50 ), generics ( Regulation 51 ), biosimilars ( Regulation 53 ) and fixed combination products ( Regulation 55 ). Food and Drug Administration, the EMA and competent authorities of Member States. law (either purely U.K.

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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.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

The Pharma Data

FEBRUARY 1, 2021

In clinical trials, the most common adverse events associated with Plegridy were injection site reactions and flu-like symptoms. Related Articles: Plegridy (peginterferon beta-1a) FDA Approval History. A list of adverse events can be found in the full Plegridy product labeling for each country where it is approved. Source link.

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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. .”

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FDA Science Regulations Production 40

The Pharma Data

AUGUST 21, 2020

Poseida suspends CAR T therapy trial in prostate cancer due to patient death. Poseida’s Phase 1 trial that used an investigational CAR T therapy for treating prostate cancer has been suspended due to a patient death. China approves its first biosimilar of Roche’s Herceptin in HER2+ cancers.

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Biosimilars Pharmacy Vaccine Pharmaceuticals 52

Agency IQ

JULY 28, 2023

September 30, 2023 PDUFA Digital Health Technologies Establish a secure cloud technology to enhance its infrastructure and analytics environment that will enable FDA to effectively receive, aggregate, store, and process large volumes of data from trials conducted using DHTs. That would leave 19% of staff affected by furloughs.

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FDA Law Blog: Biosimilars

DECEMBER 3, 2024

142, the Preserve Access to Affordable Generics and Biosimilars Act. Then, in a follow-on action in court to impose civil penalties, the liability findings made by the ALJ are treated as “conclusive” and a judge—not a jury—assesses penalties in a bench trial.

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