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.

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European Pharmaceutical Review

NOVEMBER 8, 2022

The new law will also require drug manufacturers to pay rebates to Medicare if they increase drug prices faster than consumer inflation. 3) policing anticompetitive settlements between competing drug manufacturers. Citizen Petitions before the FDA. 5) monitoring access to biosimilars. Senate Bill 562 (S.

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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.

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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. Compliance with Annex 1 and FDA requirements imposes high standards for accuracy and precision of the analytical instruments used to assess the quality of water samples. Annex 1: Manufacture of Sterile Products.

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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.

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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.

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PM360

AUGUST 9, 2022

According to an August 2021 report from the Business Research Company , after experiencing a decline in 2020 due to pandemic, the medication adherence market is expected to recover and grow at a compound annual growth rate (CAGR) of 11.4% KEEP was named in the top 100 best inventions list in TIME magazine following its launch in 2020.

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