Clinical Pharmacology, Information 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. 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

Unlike the traditional 505(b)(1) pathway, which requires extensive original investigations, the 505(b)(2) pathway allows developers to rely on information contained in published literature and/or from studies not conducted by the applicant, which can significantly reduce development time and cost. 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. For more information, please visit virpaxpharma.com or follow on Twitter, LinkedIn, and YouTube. 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

Key to the IND opening studies is that the CMC information is sufficient to support the safety of the drug substance and drug product and establish the phase-appropriate quality of the drug product. This will allow for initial evaluation and/or monitoring of the safety of the product. Contact us to learn more today!

Clinical Pharmacology

Clinical Pharmacology Production FDA Packaging

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. There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA.

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

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

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

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

Agency IQ

MAY 3, 2024

FDA’s Diversity Action Plan guidance: The FDA’s hotly-anticipated revised draft guidance document is currently under review at the White House’s Office of Information and Regulatory Affairs (OIRA), and we anticipate that it will be published over the next two months.

FDA

FDA Science Regulations Clinical Trials

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

Agency IQ

FEBRUARY 23, 2024

Whereas the prior workshops focused on certain types of therapies or the use of combination products, this newest workshop was designed to discuss “quantitative approaches to select dosages for clinical trials.” We need to factor those in to think about whether a PRO outcome in a small trial is going to be informative or not.”

Science

Science FDA Trials Clinical Pharmacology

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

Agency IQ

JULY 8, 2024

FDA Regulations and guidance under OIRA review as of July The White House’s Office of Information and Regulatory Affairs (OIRA) is the regulator of regulators, tasked with ensuring that all federal policies and regulations adhere to laws, existing regulations, federal policies and the wishes of the President.

FDA

FDA Science Regulations Production

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

Agency IQ

JUNE 16, 2023

Another addition is an advanced notice of proposed rulemaking that seeks to “obtain information related to recalls of products subject to the jurisdiction of the FDA.” For proposed and final rules with near-term planned actions, the FDA is generally more likely to release regulations when it says it plans to.

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

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED OCT 25, 2023 10:59 PM CDT Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

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

BY ALEXANDER GAFFNEY, MS, RAC | AUG 31, 2022 6:50 PM CDT | UPDATED NOV 27, 2023 10:59 PM CST Note: At the request of our subscribers, we are beginning to include information about the next two months of expected developments to make it easier for you to keep track of upcoming events.

FDA

FDA Science Regulations Production

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

Agency IQ

JULY 12, 2024

Our list contains information about when a document was first included in the Unified Agenda, which is generally a good proxy for rules that have lingered on well past their initial target date. Some rules are subject to statutory deadlines imposed by Congress, which often (though not always) compel the FDA to take timely action. and the E.C.

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

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

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

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)

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

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 July and August 2024

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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