Document, Drug Development and Pharmacokinetics

Using FDA Product Specific Guidances (PSGs) as a Trigger for Generic Drug Development

Drug Patent Watch

DECEMBER 11, 2024

These guidances serve as a roadmap for companies looking to develop generic versions of brand-name drugs, offering invaluable insights into the FDA’s expectations for demonstrating bioequivalence and ensuring product quality. Understanding FDA Product Specific Guidances Product Specific Guidances are documents issued by the U.S.

Drug Development

Drug Development Production FDA Drugs

Maximizing FDA PIND Feedback With an Optimized Nonclinical Strategy: 4 Tips to Streamlining Your Path to Clinic

The Premier Consulting Blog

APRIL 15, 2024

It is critical that the nonclinical program outlined in the PIND briefing document is presented in a manner that allows FDA to provide relevant input on the required IND-enabling studies. For example, if the nonclinical data presented in the PIND briefing document lacks information on the potential toxicity profile of the drug (e.g.,

FDA

FDA Pharmacokinetics Laboratories FDA Approval

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Conversations in Drug Development Trends

AUGUST 9, 2024

Managing this complexity highlights the importance of global communication plans and constant communication with global regulators and keeping all required documentation up to date. Coordinating these reviews across regions requires thorough documentation and clear explanations of adaptive design features.

Trials

Trials Clinical Trials Regulations FDA

Why are Post-Approval Pregnancy Studies Post-Marking Requirements Rather Than Post-Marketing Commitments?

FDA Law Blog: Drug Discovery

JANUARY 7, 2024

To better understand FDA’s approach in classifying postmarketing pregnancy studies as PMRs or PMCs, we reviewed all postmarketing requirements (PMRs) and postmarketing commitments (PMCs) related to maternal and fetal outcomes in FDA’s PMR/PMC database for drugs approved in the ten-year period from January 2014 through December 2023.

Marketing

Marketing FDA Regulations Pharmacokinetics

Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

Agency IQ

DECEMBER 1, 2023

BY RACHEL COE, MSC | NOV 27, 2023 8:24 PM CST FDA’s transition away from public health emergency (PHE)-related guidance documents The Covid-19 Public Health Emergency (PHE) was activated on January 31, 2020. Read Agency IQ’s complete breakdown of the FDA’s PHE guidance documents here.]

FDA

FDA Clinical Trials Vaccine Trials

SCYNEXIS Announces Advancement of Ibrexafungerp’s Intravenous Formulation to Clinical Stage and Provides Further Updates on its Clinical Studies in Patients with Life-Threatening Fungal Infections

The Pharma Data

DECEMBER 9, 2020

The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. The study will be conducted in South Africa. For more information, visit www.scynexis.com.

Hospitals

Hospitals Pharmacokinetics Treatment Trials

Article FDA Thank You In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward

Agency IQ

JULY 28, 2023

In a related development, this week, a new FDA guidance document to support development of medical devices to treat opioid use disorder (OUD) inched closer to release. Read AgencyIQ’s backgrounder on the FDA’s recent responses to the opioid crisis here. ]. Read the full AgencyIQ analysis here.

FDA

FDA Pharmacokinetics Clinical Pharmacology Government

Analysis Life Sciences Thank You How have pre-submission meetings for generic drug applicants changed under GDUFA III?

Agency IQ

MAY 17, 2024

How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. The generic drug user fee program is currently on its third iteration (i.e.,

Science

Science FDA Drugs Production

Analysis Life Sciences Thank You In new guidance, FDA outlines seven sources of confirmatory evidence to support single clinical studies

Agency IQ

SEPTEMBER 22, 2023

While this provision generally codified FDA practice on accelerated approval, it allowed the agency more flexibility in the types of evidence it can collect for new drugs and biologics in regulatory submissions. Analysis Sponsors should exercise caution when applying this guidance to their development programs.

FDA

FDA Science Trials Clinical Trials

Article FDA Thank You FDA’s newest draft guidance lays out considerations for developing treatments for diabetic foot infections

Agency IQ

OCTOBER 20, 2023

FDA’s newest draft guidance lays out considerations for developing treatments for diabetic foot infections In a new draft guidance document released within weeks of a related clinical practice guideline, the FDA provides considerations for developing therapies to treat diabetic foot infections, focusing on Phase 3 efficacy trials.

FDA

FDA Treatment Trials Therapies

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Agency IQ

FEBRUARY 2, 2024

The EMA started providing guidance on the clinical development of anticancer therapeutics in 1996. The document has been updated over time to implement advances in understanding cancer and drug development. In 2005, the guidance was updated to include non-cytotoxic drugs were gaining in importance.

Clinical Trials

Clinical Trials Trials Treatment Disease

Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

Science

Science FDA Trials Clinical Pharmacology

BioXcel Therapeutics Receives FDA Clearance of IND for Phase 2 Trial with BXCL501 for the Treatment of Agitation Associated with DeliriumFifth potential indication for BXCL501, an orally dissolving thin film

The Pharma Data

OCTOBER 25, 2020

In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”. is a clinical stage biopharmaceutical company focused on drug development that utilizes artificial intelligence to identify improved therapies in neuroscience and immuno-oncology.

Treatment

Treatment Trials FDA Hospitals

Article FDA Thank You FDA offers a status check on its diversity in research provisions, one year post-FDORA

Agency IQ

DECEMBER 11, 2023

BY LAURA DIANGELO, MPH | DEC 4, 2023 2:46 PM EST Diversity in clinical research: Guidance and statute In April 2022, the FDA issued a new draft guidance document on diversity in clinical research programs. Key Documents and Dates Discussing Approaches to Enhance Clinical Study Diversity Public Workshop

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Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Agency IQ

JUNE 9, 2023

FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity Late last week the FDA released a final guidance document containing recommendations on the nonclinical assessment of potential immunotoxicity for drugs and certain biologics.

FDA

FDA Small Molecule Science Immune Response

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Agency IQ

DECEMBER 11, 2023

By our count, the FDA’s Oncologic Drugs Advisory Committee held seven meetings in 2023; additionally, the Oncology Center of Excellence authored nine new (draft) and six final guidance documents. At the start of the year, FDA published a guidance document, not specific to oncology, on the use of external controls. What’s ahead?

FDA

FDA Science Clinical Trials Trials

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

166 guidance documents the FDA is actively working on in 2024 (and beyond) The FDA is set to be very, very busy in 2024. We’ve identified a total of 166 guidance documents that are under active development, and have the key details for you below. Some of those documents may also take years to be completed.

FDA

FDA Science Biosimilars Clinical Trials

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. This study is planned to start in late 2024 and conclude in late 2025.

FDA

FDA Trials Therapies Regulations

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. This list is known as the FDA’s “guidance agenda.”

Analysis Life Sciences Thank You FDA solidifies its advice on dose optimization for oncology products

Agency IQ

AUGUST 16, 2024

In this analysis, AgencyIQ has combed through the newly released final guidance document to tease out what’s new and what’s the same. Another addition to FDA’s general advice is a recommendation for sponsors to engage early with the FDA “early in clinical development” (as opposed to “at relevant milestone meetings”).

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Production FDA Science Clinical Trials

Article EMA Thank You Overdue EMA reflection paper on drug dosing in obesity introduces more questions than answers

Agency IQ

FEBRUARY 23, 2024

Overdue EMA reflection paper on drug dosing in obesity introduces more questions than answers Although the prevalence of overweight and obesity in Europe exceeds 50%, the EMA does not currently offer guidance to sponsors on investigating the effects of obesity during drug development.

Drugs

Drugs Clinical Trials Pharmacokinetics Drug Development

Better Late Than Never – Unpacking FDA’s Highly Anticipated (and Long Overdue) Draft Guidance on Diversity Action Plans

FDA Law Blog: Drug Discovery

JULY 9, 2024

DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety. 510(k) submission, De Novo classification request, Premarket Approval (“PMA”) application).

FDA

FDA Clinical Trials Disease Trials

Analysis Life Sciences Thank You FDA just published its Diversity Action Plan guidance. Here’s what you need to know.

Agency IQ

JUNE 28, 2024

In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. The new draft document, separate from the DAP guidance, offers recommendations for the standards for collecting and reporting race and ethnicity data in regulatory submissions.

FDA

FDA Science Clinical Trials Production

Drug Discovery Digest

Using FDA Product Specific Guidances (PSGs) as a Trigger for Generic Drug Development

Maximizing FDA PIND Feedback With an Optimized Nonclinical Strategy: 4 Tips to Streamlining Your Path to Clinic

Trending Sources

Establishing Effective Adaptive Trial Designs for Oncology in Multi-Regional Studies

Why are Post-Approval Pregnancy Studies Post-Marking Requirements Rather Than Post-Marketing Commitments?

Article FDA Thank You FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version

SCYNEXIS Announces Advancement of Ibrexafungerp’s Intravenous Formulation to Clinical Stage and Provides Further Updates on its Clinical Studies in Patients with Life-Threatening Fungal Infections

Article FDA Thank You In new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward

Analysis Life Sciences Thank You How have pre-submission meetings for generic drug applicants changed under GDUFA III?

Analysis Life Sciences Thank You In new guidance, FDA outlines seven sources of confirmatory evidence to support single clinical studies

Article FDA Thank You FDA’s newest draft guidance lays out considerations for developing treatments for diabetic foot infections

Article EMA Thank You EMA finalizes clinical anticancer therapeutic guidance update

Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

BioXcel Therapeutics Receives FDA Clearance of IND for Phase 2 Trial with BXCL501 for the Treatment of Agitation Associated with DeliriumFifth potential indication for BXCL501, an orally dissolving thin film

Article FDA Thank You FDA offers a status check on its diversity in research provisions, one year post-FDORA

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

Analysis Life Sciences Thank You FDA solidifies its advice on dose optimization for oncology products

Article EMA Thank You Overdue EMA reflection paper on drug dosing in obesity introduces more questions than answers

Better Late Than Never – Unpacking FDA’s Highly Anticipated (and Long Overdue) Draft Guidance on Diversity Action Plans

Analysis Life Sciences Thank You FDA just published its Diversity Action Plan guidance. Here’s what you need to know.

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