H1 Blog

NOVEMBER 15, 2023

But in today’s highly regulated environment, it is more important than ever to make sure that HCP engagement plans are compliant with anti-kickback laws. Since KOLs play such a critical role, engaging with the right KOLs is a key strategy for pharmaceutical companies to stay ahead of the game.

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Compliance Science Regulations Pharmaceutical Companies 59

PPD

AUGUST 28, 2024

For pharmaceutical innovators and drug developers working to bring oncology therapies to market, patients are the “why” behind it all. Regulators and payors also demand a higher volume of data collection for these studies. For many patients, involvement in oncology clinical trials represents a last hope for an effective therapy.

Trials 64

Trials Clinical Trials Therapies Drug Development 64

Agency IQ

JULY 7, 2023

What is the state of pharmaceutical quality in the U.S.? Call it murky A new report published by the FDA’s Office of Pharmaceutical Quality (OPQ) promises a look at the current “State of Pharmaceutical Quality.” Read AgencyIQ’s analysis of FDA’s QMM White Paper here.]

Pharmaceuticals 40

Pharmaceuticals Science FDA Production 40

Agency IQ

NOVEMBER 10, 2023

BY ALEXANDER GAFFNEY, MS, RAC | NOV 9, 2023 6:35 PM CST Background on CDER’s Office of Pharmaceutical Quality (OPQ) CDER’s Office of Pharmaceutical Quality became operational in January 2015, making it a still relatively recent addition to the agency. Read AgencyIQ’s analysis of FDA’s QMM White Paper here.]

Pharmaceuticals 40

Pharmaceuticals Small Molecule Science FDA 40

Agency IQ

FEBRUARY 21, 2024

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

Science 40

Science Regulations International FDA 40

Drug & Device Law

JULY 31, 2023

It’s an interesting topic; Eric recently wrote a paper on it , and Bexis is putting together a “white paper” for the Product Liability Advisory Council on the same subject. 2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. Medicis Pharmaceutical Corp. ,

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Production International Trials Government 52