Clarify Health

OCTOBER 26, 2021

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. In fact, 73% were White, 14% were Asian, 6% were Hispanic, and 5% were African American.

Food and Drug Administration 52

Food and Drug Administration Recruitment Pharmaceutical manufacturing Medical 52

Impetus Digital

AUGUST 2, 2024

Unsurprisingly, the US FDA has reported a noticeable increase in the number of submissions that use AI/machine learning (ML) components in recent years; in 2021, they received more than 100 submissions wherein AI use was reported. Looking back at 2023 , AI for drug discovery saw both wins and losses.

Pharma 95

Pharma Manufacturing Medicine Marketing 95

PM360

DECEMBER 20, 2023

market (source: IQVIA MIDAS, May 2023). At the same time, a “drug lag” persists in China for global pharmaceutical companies’ products. billion people in 2023). Pharmaceutical companies can sell drugs with free pricing in the GBA and Hainan Boao after obtaining foreign approval (e.g., in the U.S.

Marketing 105

Marketing Insurance Medical Manufacturing 105

European Pharmaceutical Review

JULY 21, 2023

Manufacturing delays and capacity issues that continue to impact the pharmaceutical supply chain have led to medicine shortages around the globe; an issue that has been exacerbated further by geopolitical events, the energy crisis and rising inflation. What types of medicinal products are in short supply and why?

Pharmaceutical 98

Pharmaceutical Food and Drug Administration Transportation Manufacturing 98

PM360

OCTOBER 25, 2023

Combination Therapy in Oncology Combination therapies comprising two or more therapeutic agents have become a cornerstone of oncology management and are increasingly a development focus for the pharmaceutical industry. Food and Drug Administration (FDA) oncology approvals were for drugs used in combination. Certain markets (e.g.,

Food and Drug Administration 105

Food and Drug Administration Manufacturing Marketing Pharmaceutical manufacturing 105

European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. Eight FDA warning letters were handed to European companies in 2018.

FDA 98

FDA Food and Drug Administration Media Pharmaceutical 98

PM360

APRIL 25, 2023

biosimilars market to date, the first of eight FDA-approved Humira (adalimumab) biosimilars launched in the United States in January after years of regulatory delays. Although AbbVie’s patent for Humira officially expired in 2016, the legal and regulatory delays paused competition for Humira until 2023. pharmaceutical industry.

Marketing 97

Marketing Competition Government Manufacturing 97

PM360

AUGUST 9, 2022

The FDA 510(k) submission is expected to take place in Quarter 3 2023. Launched in July 2021, Prescryptive Health provides next-generation, mobile market access and medication adherence solutions for pharmaceutical manufacturers. Orbita Outreach. Patty Riskind. hello@orbita.ai.

Prescription 105

Prescription Medical Patients Side effects 105

Pharmaceutical Technology

MARCH 22, 2023

To keep the EU’s medicine supply intact, Gupta suggests governments should adopt new pricing policies and provide further aid to mitigate the impact of rising operational costs; they should also minimise the exodus of generics manufacturers.

Food and Drug Administration 105

Food and Drug Administration Manufacturing Government Pharmaceutical 105