Clinical Pharmacology and Packaging - Drug Discovery Digest

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. food effect, smoking, and drug-drug interactions) on drug exposure and response.

Clinical Pharmacology

Clinical Pharmacology Drug Development Pharmacokinetics Drugs

Shaping drug development success: how does artwork play a role?

Drug Target Review

AUGUST 7, 2024

The preclinical role of often-overlooked artwork During preclinical stages, labelling decisions can significantly impact clinical trials and eventual drug commercialisation. Packaging is typically the patient’s first interaction with a product, and it is critical for communicating safety and benefit-risk information.

Drug Development

Drug Development Clinical Pharmacology Clinical Trials Packaging

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

The Premier Consulting Blog

SEPTEMBER 11, 2024

The 505(b)(2) submission for Bendeka included a complete chemistry, manufacturing, and controls (CMC) package, but relied on the drug master file (DMF) for Treanda. The overall development strategy for GT123 was to include a complete CMC package. daily versus four times daily dosing).

Drugs

Drugs Clinical Pharmacology Packaging Small Molecule

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. “We are very pleased to be working with Virpax again and are satisfied with the trajectory our studies have taken. The final step for this program will be a bioanalytical sample analysis.

Virus

Virus Clinical Pharmacology Drugs FDA Approval

CMC Considerations for Pre-IND Meetings

The Premier Consulting Blog

NOVEMBER 4, 2023

Conclusion The goals of a pre-IND meeting always include minimizing regulatory and execution risks in a drug development program through well-defined clinical, clinical pharmacology, nonclinical, and CMC development plans. Contact us to learn more today! Authors : Ryan Key, PhD, Davar Khossravi, PhD, Olu Aloba, PhD.

Clinical Pharmacology

Clinical Pharmacology Production FDA Packaging

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

Data from the completed studies of zuranolone in the LANDSCAPE and NEST clinical development programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package.

Treatment

Treatment Clinical Pharmacology Drugs Clinical Development

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

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology. 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 FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

AgencyIQ compiled these data using information in approval letters and review packages posted to the Drugs@FDA database. While the definition of NME has changed over the years, it can sometimes include a combination product consisting of at least one drug that has previously been approved. What’s next? Stay tuned.

FDA

FDA Biosimilars Science Production

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

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 (..)

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

Letter Program Tag Commitment Due Date PDUFA Advancing RWE Program Report containing aggregated and anonymized information describing RWE submissions to CDER and CBER.

FDA

FDA Science Regulations Production

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

Agency IQ

FEBRUARY 23, 2024

I’m not going to say which one is better,” said JIANG LIU, scientific lead at the FDA’s Division of Pharmacometrics in the Office of Clinical Pharmacology. Then, a bit later but still in early-phase studies, developers can leverage this pharmacology information in innovative approaches that may incorporate modeling.

Science

Science FDA Trials Clinical Pharmacology

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

Agency IQ

JUNE 16, 2023

0910-AI84 December 2023 Final Rule Stage Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

Regulations

Regulations FDA Science Production

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

Agency IQ

OCTOBER 27, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

FDA

FDA Science Regulations Production

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

Agency IQ

DECEMBER 1, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

FDA

FDA Science Regulations Production

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

Agency IQ

JULY 12, 2024

Fall 2023 July 2024 Final Rule Amendment to Establishment Registration and Device Listing Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated as Devices Fall 2022 July 2024 Final Rule Prior Notice: Adding Requirement to Submit Mail Tracking Number for Articles of Food Arriving by International Mail (..)

Regulations

Regulations FDA Science Production

Drug Discovery Digest

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

Shaping drug development success: how does artwork play a role?

Trending Sources

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

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

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)

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

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

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

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

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

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

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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