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 52

Clinical Pharmacology Drug Development Pharmacokinetics Drugs 52

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 59

Drug Development Clinical Pharmacology Clinical Trials Drugs 59

The Premier Consulting Blog

NOVEMBER 4, 2023

If an excipient is not listed in the IID or is present in levels exceeding the IID, justification of the use level is required and may involve non-clinical subject matter experts. If the drug product is part of a drug-device combination, considerations for the drug component of the combination will be the same as those presented above.

Clinical Pharmacology 52

Clinical Pharmacology Production FDA Packaging 52

Agency IQ

JULY 8, 2024

Start Date End Date Event Event Type Center 07/10/2024 07/10/2024 Medical Device Sterilization Town Hall: Mock Pre-Submission on Implementing a Change in Sterilization Method Webcast CDRH 07/10/2024 07/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Exploring Religious Literacy and Spirituality in Cancer Care” Webcast (..)

FDA 40

FDA Science Regulations Production 40

Agency IQ

FEBRUARY 23, 2024

In between, panelists and presenters also discussed alternative designs for dose-finding trials and creative strategies for evaluating and modeling early clinical data. 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.

Science 40

Science FDA Trials Clinical Pharmacology 40

Agency IQ

JUNE 16, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

OCTOBER 27, 2023

Government shutdown: At present, the U.S. Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. Expect nearly every company to be closely reading this document when it’s eventually published.

FDA 40

FDA Science Regulations Production 40