Rethinking Clinical Trials

DECEMBER 14, 2022

The post Grand Rounds Ethics and Regulatory Series December 9, 2022: The Stepped Wedge Cluster Randomized Trial: Friend or Foe? During the Ebola crisis, the ethical argument for stepped wedge CRTs was that anything involving a placebo in the control arm was automatically considered unethical if the intervention arm holds a chance of benefit.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

pharmaphorum

SEPTEMBER 15, 2020

“Digitally native brands are typically agile businesses from the ground up, and agility and flexibility are part of their core makeup,” says Joe Holmes, vice president, marketing services, US at Tag. Jeremy Richter, Tag. Joe began his life at Tag in the UK, bringing efficiencies to his clients, working across all conceivable channels.

Branding 114

Branding Marketing Pharma Companies Life Science 114

pharmaphorum

AUGUST 21, 2022

The biotech hasn’t revealed much information about the reasons for the delay in getting approval, but said in an SEC filing in June this year that it had agreed to “post-marketing commitments” proposed by the FDA, without going into details.

Drugs 96

Drugs FDA Approval Production Marketing 96

Rethinking Clinical Trials

AUGUST 28, 2023

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. Time, cost and failure to recruit trial participants are significant barriers that must be addressed. The guidance should not remove the need to think.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Rethinking Clinical Trials

AUGUST 28, 2023

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. Time, cost and failure to recruit trial participants are significant barriers that must be addressed. The guidance should not remove the need to think.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Camargo

AUGUST 22, 2021

The first two were published in December of 2014: Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act mandates that NDAs, ANDAs, and INDs be submitted in electronic format. The correct STF file-tags are used for datasets and corresponding data definition files.

Containment 190

Containment Bioavailability Cosmetics Packaging 190

The Pharma Data

MAY 5, 2021

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. . AbbVie’s Humira regains top pharma TV spender spot, while sibling brands Rinvoq and Skyrizi tag along ( Fierce ). Government & Regulatory. Remote Regulatory Assessments ( FDAatty ).

Vaccination 52

Vaccination Vaccine Gene Therapy Contract Packaging 52