pharmaphorum

JULY 6, 2022

And how can regulators balance timely access with robust safety? A European Federation of Pharmaceutical Industries and Associations (EFPIA) report published earlier this year, for example, compared the timelines of six regulatory agencies between 2011 and 2020. Accelerating safe access.

Safety 93

Safety FDA Medicine Patients 93

European Pharmaceutical Review

DECEMBER 14, 2023

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. Meta-analyses contributed least frequently (31.4

Medicine 116

Medicine Safety Competition Networking 116

Legacy MEDSearch

JANUARY 13, 2023

The IDE Study is being conducted to determine the safety and effectiveness of the HIT Reverse HRS in Primary Total Hip Arthroplasty (THA). Safety will be assessed through the collection of device-related adverse events and patient quality of life metrics. About Hip Innovation Technology, LLC.

FDA 98

FDA Safety Recruitment Patients 98

Clarify Health

AUGUST 26, 2020

Prior to 2011 when the Affordable Care Act (ACA) was passed, many insurance companies were spending a large portion of premium dollars on administrative costs and profits. Health plans should prioritize high-value providers to include in their network based on case-mix adjusted clinical, quality and cost-efficiency scores.

Insurance 52

Insurance Medical Networking Management 52

Pharma Marketing Network

MARCH 25, 2022

Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Findings note that caregivers are a vital source of information. Sunny White. February 2019.

Pharma 98

Pharma Education Training Transportation 98

Legacy MEDSearch

JULY 21, 2023

This first-in-female procedure was approved by the National Agency for the Safety of Medicines and Health Products (or ANSM, the French equivalent to the U.S. Food and Drug Administration). “It’s magic,” the patient stated, as the first woman to activate the novel UroActive device.

Food and Drug Administration 52

Food and Drug Administration Patients Safety Recruitment 52

European Pharmaceutical Review

SEPTEMBER 22, 2022

11 have recently conducted an analysis of international HTA submissions from 2011-2019 to determine the acceptability of single arm clinical studies and ECs as part of the drug reimbursement process. He is a member of the EMEA’s European Network of Centres for Pharmacoepidemiology and Pharmacovigilance ( www.encepp.eu ). Patel et al.

Food and Drug Administration 122

Food and Drug Administration Patients Distribution FDA 122