FDA Law

MARCH 6, 2024

HP&M is proud to have our professionals participating in these important events. Kurt provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. We can offer our readers a special discount for the event.

Management 59

Management Manufacturing Specialization Government 59

FDA Law

MAY 8, 2023

The discussion paper described a PCCP as including (1) the types of anticipated modifications (SaMD Pre-Specifications or SPS) based on the retraining and model update strategy and (2) the associated methodology (Algorithm Change Protocol or ACP) being used to implement those changes in a controlled manner to manage patient risks.

Manufacturing 98

Manufacturing Provider Medical IT 98

FDA Law

MARCH 9, 2025

The conference is the premier event on cosmetics and personal care products, where industry leaders will provide essential updates on compliance with Modernization of Cosmetics Regulation Act of 2022 (MoCRA), state legislative reforms, and new FTC advertising guidelines. You can access the conference brochure and sign up for the event here.

Manufacturing 59

Manufacturing Specialization Provider Management 59

FDA Law

FEBRUARY 26, 2025

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. The answer to that is still no, the current state of world and governmental events notwithstanding. By John W.M.

Supply Chain 66

Supply Chain Management Manufacturing IT 66

FDA Law

SEPTEMBER 22, 2024

Complaints FDA discussed how LDT developers should handle the transition from the current Quality System Regulation (QSR)(21 CFR Part 820) to the recently promulgated Quality Management System Regulation (QMSR) that is scheduled to take effect on February 2, 2026. SCH : LDT, approved by NYS CLEP. It should be noted that 21 CFR 803.18(b)(1)(ii)

Manufacturing 64

Manufacturing Electronics Provider Management 64

FDA Law

JUNE 6, 2021

FDA requirements applicable to sponsors of drug-led drug/device combination products, including device requirements for the quality management system and good manufacturing practices (GMPs), device content to include in a new drug application (NDA), registration and listing, and post market reporting. This webcast will cover U.S.

Manufacturing 52

Manufacturing Management 52

Physician's Practice

JUNE 9, 2025

Financial Relationships with Pharmaceutical Companies (00:20:10)** Legal and ethical concerns for physicians with financial ties to GLP-1 drug manufacturers, including anti-kickback laws. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. Adler, J.D., Adler, J.D.,

Management 52

Management Telemedicine Patients Insurance 52