European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

FDA 89

FDA Food and Drug Administration Pharma Pharmaceutical manufacturing 89

World of DTC Marketing

APRIL 7, 2021

QUICK READ: The compensation for pharma CEOs is starting to be reported and it’s off the charts. Pharma, PBM, and health insurance CEOs earn hundreds of millions of dollars to do one thing; make their companies a lot of money. drug spending by 9 percent” What about taxpayers? Bob Bradway of Amgen bagged a $20.1

Healthcare 162

Healthcare Healthcare Food and Drug Administration Pharma 162

PM360

OCTOBER 28, 2022

Shepherding a new drug to market is a long, expensive, and uncertain process. billion dollars to bring a new drug from discovery to regulatory approval and market launch. Approval success rates of drug candidates are between 10%–20% in the United States, the European Union, and Japan. in 2010 to only 1.9%

Pharma 105

Pharma Food and Drug Administration Government Medicine 105

European Pharmaceutical Review

OCTOBER 20, 2022

An essential part of the manufacturing of drug products is the use of water of different degrees of purity. 1 The last four are produced at separate plants and thus less discussed for pharma since they are unlikely to be producing them in house. Water quality from an Annex 1 and Pharma 4.0 US Food and Drug Administration.

Food and Drug Administration 86

Food and Drug Administration Pharma Manufacturing Food 86

Clarivate

MAY 24, 2022

Recent policy and regulatory moves have begun to sketch out a framework for rare disease drug approvals in the country, but obstacles to approvals and patient access remain. The list, designed to serve as a reference point for prioritized drug review and evaluation policies, included 121 rare diseases. [8].

Patients 52

Patients Food and Drug Administration Marketing Pharma 52

World of DTC Marketing

NOVEMBER 12, 2020

According to JAMA , “between January 2010 and June 2020, the FDA approved 21 vaccines, most commonly for influenza (5 [23.8%]) and meningococcus (5 [23.8%]). The median premarket clinical development period (investigational new drug submission to FDA approval) was 8.1 Ken Catalino / Creators Syndicate.

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Food and Drug Administration FDA Distribution Government 187