Clinical Pharmacology, FDA and Packaging

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

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

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Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. Section #1: FDA Interactions Given the wide range of sponsors (i.e., The draft guidance recommends that no more than 15 questions are included in the briefing package.

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

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

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 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

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

Once samples are validated, this will conclude the IND package” said Kyle Klepner, Senior Scientist, Study Director, Safety Assessment, at Altasciences. Virpax is initially seeking FDA approval for two prescription drug candidates that employ two different patented drug delivery platforms.

Virus

Virus Clinical Pharmacology Drugs FDA Approval

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

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. Contact us to learn more today! Authors : Ryan Key, PhD, Davar Khossravi, PhD, Olu Aloba, PhD.

Clinical Pharmacology

Clinical Pharmacology Production FDA Packaging

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

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 The 53 regulations that FDA is currently working on

Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

Regulations

Regulations FDA Science Production

Drug Discovery Digest

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

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

Trending Sources

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

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

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

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

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

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

CMC Considerations for Pre-IND Meetings

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

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

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

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