FDA Law

MARCH 6, 2024

HP&M is proud to have our professionals participating in these important events. Charles assists clients across a range of FDA-related regulatory matters by providing timely strategic advice on new drug and biologic development and helping them tackle complex regulatory issues. On March 20-21, Counsel John W.M.

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. FDA Law Blog is a conference media partner.

Manufacturing 59

Manufacturing Specialization Provider Management 59

FDA Law

SEPTEMBER 22, 2024

Instead, we focus here on the few notable statements that provide new or more detailed guidance than FDA has previously offered. MDR FDA discussed a few preliminary steps that it says laboratories should take prepare for submitting MDRs as medical device manufacturers. By Steven J. Gonzalez & Lisa M.

Manufacturing 64

Manufacturing Electronics Provider Management 64

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

Physician's Practice

JUNE 9, 2025

Conclusion and Closing Remarks (00:25:02)** Thanking the guest, closing the episode, and providing subscription information. 68: Hidden risks of prescribing GLP-1 drugs with Ericka L. 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 Insurance Patients 52

CDOCS

MAY 4, 2021

Couple this with the in-office technologies of CEREC&reg; Primescan and CBCT allowed us to gain control of the technical processes necessary to manage and produce the surgical and restorative phases of treatment at one location.</span></p> Routinely a 25-40% reduction in cost as compared to the dental lab.

Patient-Centered 52

Patient-Centered Patients Manufacturing Provider 52