Clinical Pharmacology and FDA - Drug Discovery Digest

AdComms – Is FDA Getting Less Advice?

Eye on FDA

AUGUST 4, 2021

As more drugs are being approved, is FDA getting less advice than in the past? 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. There are 31 advisory committees on matters ranging from food to medical devices to pediatric care.

FDA

FDA Clinical Pharmacology FDA Approval Therapies

At Long Last, FDA Unveils Plan for Rare Disease Innovation Hub

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. By Sarah Wicks & James E. Valentine & Frank J. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

FDA

FDA Disease Clinical Pharmacology Science

Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval?

Fierce BioTech

OCTOBER 26, 2023

Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval? Eva Gil Berglund, PhD Justin Hay, PhD Paola Coppola, MSc Duration 60 Minutes Clinical pharmacology information comprises more than 50% of a drug label. Click here to login. Listing Image Certara-LogoListing-12052023.png

Clinical Pharmacology

Clinical Pharmacology Drug Development Regulations FDA

Clinical Pharmacology Considerations for Peptide Drug Products

thought leadership

SEPTEMBER 20, 2023

The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products. A peptide is any polymer with 40 or fewer amino acids. These products fall somewhere between drugs and biologics and do not have the usually well-defined characteristics of either category.

Clinical Pharmacology

Clinical Pharmacology Production Small Molecule Drugs

Optimized 505(b)(1) and 505(b)(2) Clinical Pharmacology Programs to Accelerate Drug Development

The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

Clinical Pharmacology

Clinical Pharmacology Drug Development Pharmacokinetics Drugs

FDA Advisory Committee Review of 2021

Eye on FDA

JANUARY 5, 2022

FDA has scheduled the first advisory committee meetings of 2022. First and foremost is that as noted earlier this year (See August 5, 2021 FDA Adcomms – Is FDA Getting Less Advice? ), there were fewer 2021 meetings held to consider new drug applications than in years gone by. FDA Outcomes.

FDA

FDA Clinical Pharmacology Vaccine Production

Antibody Drug Conjugates: windows of opportunity

Drug Target Review

JULY 4, 2023

However, a more detailed look into the clinical data suggests that there is room for further dose optimisation, and this is exemplified by the small molecule drug Sotorasib. FDA initiatives to support dose optimization in oncology drug development: the less may be the better. Translational and Clinical Pharmacology [Internet].

Small Molecule

Small Molecule Drugs Clinical Pharmacology Trials

News from ESMO: Challenging the Status Quo of Early Phase Clinical Trial Design — Moving from “Why” to “How”

Cytel

OCTOBER 27, 2023

Speakers discussed investigator, regulatory (FDA), industry, and patient perspectives during the special symposium “Challenging the Status Quo of Early Phase Clinical Trial Design: Project Optimus.” To address this challenge, the FDA Oncology Center of Excellence initiated Project Optimus.

Clinical Trials

Clinical Trials Trials Clinical Pharmacology Clinical Development

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Conversations in Drug Development Trends

FEBRUARY 21, 2024

While traditionally conducted during Phase 2 or later, the FDA has recently been requesting data sooner in the development process, making it critical to implement proactive AME studies to lay the groundwork for advanced phases of your clinical program. To accomplish this, we pay careful attention to both dosing and sample collection.

Clinical Trials

Clinical Trials Pharmacy Clinical Pharmacology FDA

Webinar: Assessing Cognition Impairment Using Driving Simulators in Clinical Trials

Alta Sciences

FEBRUARY 8, 2024

The FDA guidance, Evaluating Drug Effects on the Ability to Operate a Motor Vehicle , indicates that testing in early-phase clinical development should emphasize sensitivity over specificity in CNS effects.

Clinical Trials

Clinical Trials Trials Clinical Pharmacology Clinical Development

Strategies for Recovering from an Unsatisfactory Pre-IND Meeting

The Premier Consulting Blog

JUNE 8, 2023

Premier Consulting’s regulatory strategists specializing in the US FDA’s 505(b)(2) approval pathway are often asked how a sponsor can recover from a pre-IND meeting that doesn’t go as planned. Start by analyzing the feedback received during the meeting and thoroughly reviewing the FDA’s recommendations and suggestions.

Clinical Pharmacology

Clinical Pharmacology FDA Drug Development Clinical Trials

Eplontersen

New Drug Approvals

DECEMBER 24, 2023

“Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. Food and Drug Administration (FDA). 7 March 2023. .

Clinical Trials

Clinical Trials FDA Clinical Pharmacology Pharmacokinetics

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms AgencyIQ analyzed CDER’s novel drug approvals in Fiscal Year 2023, identifying a recovery in approval numbers as the agency resumes a new normal following the pandemic. The FDA also refers to novel products as “New Molecular Entities,” or NMEs.

FDA

FDA Biosimilars Science Production

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 new contract notices, FDA seeks help on user fee commitments and moving opioid, oncology priorities forward This week, the FDA issued four new contract notices that highlight agency priorities in meeting user fee commitments, ongoing work in oncology dose optimization, and continued commitment to addressing the opioid crisis.

FDA

FDA Pharmacokinetics Clinical Pharmacology Government

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. Section #1: FDA Interactions Given the wide range of sponsors (i.e., Tobolowsky & Charles G. Raver & James E.

Therapies

Therapies FDA Production Disease

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

FDA Science Regulations Clinical Trials

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

Agency IQ

DECEMBER 1, 2023

FDA updates guidance on developing drugs for Covid-19, replacing pandemic-era version Last week, FDA published the third update to its guidance on the development of products to prevent or treat Covid-19. The FDA also implemented new flexibilities for certain regulated products and processes, typically via enforcement discretion.

FDA

FDA Clinical Trials Vaccine Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. We will see if FDA is willing to accept those changes later this month.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. AgencyIQ October 1 Nitrosamine testing due to FDA.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. FDA’s most recent agenda doubles down on that December 2023 anticipated due date, however.

Regulations

Regulations FDA Science Production

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

Agency IQ

DECEMBER 11, 2023

The FDA and oncology: 2023 year in review As we round the corner into the last few weeks of 2023, AgencyIQ has taken a look back at a very busy year for the FDA’s oncology staff, and for sponsors. Since its inception, OCE has initiated an extensive list of initiatives and has taken the lead on over forty guidances published by FDA.

FDA

FDA Science Clinical Trials Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. In 2022 and 2021, the Spring Unified Agenda was released in early/mid June.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. FDA is also due to revise 24 other guidance documents at that time.

FDA

FDA Science Regulations Production

A Closer Look At Our On-Site Compounding Pharmacies

Alta Sciences

DECEMBER 14, 2023

Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA. Regulatory Excellence - Licenses for Schedule I through IV drug substances.

Compounding Pharmacies

Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply

In Silico Modeling Unveils a New Era in Rare Disease Drug Development

The Premier Consulting Blog

JUNE 18, 2023

Figure 1: Comparison of Clinical Trial Designs The Prelude to Applying In Silico Trials for Rare Diseases In silico clinical trials have been recognized by the FDA as useful tools in advancing personalized treatment and streamlining randomized controlled trials. Accessed April 4, 2023, at: [link] [2] Russo et al.

Drug Development

Drug Development Disease Clinical Trials Drugs

Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI)

Alta Sciences

AUGUST 28, 2023

Ischemix expects to complete all of the work required for a Phase II trial of CMX-2043 in acute TBI by the end of 2023, and plans to request a pre-IND meeting with FDA for early Q1 2024. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions.

Trials

Trials Treatment Clinical Pharmacology Pharmacokinetics

Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)

The Pharma Data

MAY 2, 2022

Food and Drug Administration (FDA) for zuranolone in the treatment of major depressive disorder (MDD). The companies have submitted the nonclinical module of the NDA to the FDA and plan to submit the remaining components for the MDD filing in the second half of 2022.

Treatment

Treatment Clinical Pharmacology Drugs Clinical Development

Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses

Alta Sciences

SEPTEMBER 20, 2023

About Altasciences Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.

Virus

Virus Clinical Pharmacology Drugs FDA Approval

CMC Considerations for Pre-IND Meetings

The Premier Consulting Blog

NOVEMBER 4, 2023

The pre-IND meeting is an opportunity for highly productive interactions between sponsors and the FDA, allowing for discussion of key material attributes and development strategy plus requests for Agency review and advice on specific topics.

Clinical Pharmacology

Clinical Pharmacology Production FDA Packaging

Navigating the 505(b)(2) Pathway: No Two Drugs Are Alike

The Premier Consulting Blog

SEPTEMBER 11, 2024

However, the success of a 505(b)(2) application hinges on a tailored development strategy that carefully considers the specific characteristics of the newly proposed drug product, and the nature of the changes made in comparison to a prior US FDA-approved listed drug (LD) or the drug reported in literature.

Drugs

Drugs Clinical Pharmacology Packaging Small Molecule

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

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.

Science

Science Biosimilars FDA Production

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

Metabolism of macrocyclic drugs

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. of parent drug exposure respectively.

Drugs

Drugs Metabolic Stability FDA Approval Treatment

Metabolism of de novo designed macrocyclic drugs

Metabolite Tales Blog

JULY 5, 2023

Metabolism of de novo-designed macrocyclic drugs approved by the FDA By Julia Shanu-Wilson To date, only 4% (67) of FDA approved drugs are macrocycles [1]. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders.

Metabolic Stability

Metabolic Stability Drugs FDA Approval Treatment

TLC Provides Corporate Update at Investor Conference – Dec 18, 2020

The Pharma Data

DECEMBER 17, 2020

In addition, TLC is preparing for scale-up production of TLC590, as for complex lipid products, the manufacturing process and batch size used in pivotal clinical trials and New Drug Application submission must be the same as future commercial batches.

Clinical Trials

Clinical Trials Trials Pharmaceutical Companies Clinical Pharmacology

Janssen Presents Results from Phase 3 ACIS

The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. FDA on April 28, 2011 and by the European Commission on September 7, 2011. FDA on February 8, 2018. [vi] 2 ERLEADA ® received U.S. ERLEADA ® is taken orally, once daily, with or without food.

Pharmaceutical Companies

Pharmaceutical Companies Treatment Clinical Trials Therapies

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

SEPTEMBER 15, 2023

FDA’s nonprescription advisors find no efficacy for phenylephrine This week, FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted unanimously that current scientific data do not support the efficacy of oral phenylephrine as a nasal decongestant, aligning with FDA analysis — and re-analysis — of data.

Science

Science FDA Clinical Trials Clinical Pharmacology

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. This is already proving to be one of the FDA’s most-opposed actions in years.

FDA

FDA Science Regulations Production

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. For now, we haven’t included all documents previously released by the FDA in draft form unless specifically included on the agency’s draft agendas. New on CDRH’s guidance agenda. Priority A List.

FDA

FDA Science Biosimilars Clinical Trials

Top 10 Life Science Resources for Summer 2024

Alta Sciences

JULY 25, 2024

To ensure you're in the know, we've put together a summary of recent revisions, drafts, and final guidances from the FDA. jpg Synopsis Discover 10 more essential life science resources, including expert insights, tips, case studies, webinars, podcasts, posters, scientific publications, videos, and more, that you may have missed from us!

Science

Science Clinical Trials Clinical Pharmacology FDA

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

Agency IQ

MARCH 1, 2024

What We Expect the FDA to do in March and April 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. FDA has been holding bi-monthly “Town Hall” meetings to prepare.

FDA

FDA Science Clinical Trials Regulations

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

Agency IQ

FEBRUARY 12, 2024

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” This list is known as the FDA’s “guidance agenda.”

Top 10 Life Science Resources

Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Watch the video.

Science

Science Clinical Trials Pharmacokinetics Pharmacy

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA

FDA Science Clinical Trials Regulations

AdComms – Is FDA Getting Less Advice?

At Long Last, FDA Unveils Plan for Rare Disease Innovation Hub

Trending Sources

Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval?

Clinical Pharmacology Considerations for Peptide Drug Products

Optimized 505(b)(1) and 505(b)(2) Clinical Pharmacology Programs to Accelerate Drug Development

FDA Advisory Committee Review of 2021

Antibody Drug Conjugates: windows of opportunity

News from ESMO: Challenging the Status Quo of Early Phase Clinical Trial Design — Moving from “Why” to “How”

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Webinar: Assessing Cognition Impairment Using Driving Simulators in Clinical Trials

Strategies for Recovering from an Unsatisfactory Pre-IND Meeting

Eplontersen

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

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

FDA Issues “Cliffs Notes”-style Guidance on Cell and Gene Therapy; What Questions Did They Answer? (Part 1)

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

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

Analysis Life Sciences Thank You What We Expect the FDA to do in July and August 2024

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

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

Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

A Closer Look At Our On-Site Compounding Pharmacies

In Silico Modeling Unveils a New Era in Rare Disease Drug Development

Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI)

Sage Therapeutics and Biogen Initiate Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administration for Zuranolone for the Potential Treatment of Major Depressive Disorder (MDD)

Altasciences Chosen by Virpax to Support the Development of a New Drug to Prevent Spread of Flu-like Viruses

CMC Considerations for Pre-IND Meetings

Navigating the 505(b)(2) Pathway: No Two Drugs Are Alike

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

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

Metabolism of macrocyclic drugs

Metabolism of de novo designed macrocyclic drugs

TLC Provides Corporate Update at Investor Conference – Dec 18, 2020

Janssen Presents Results from Phase 3 ACIS

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

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

Top 10 Life Science Resources for Summer 2024

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

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

Top 10 Life Science Resources

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Stay Connected