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

European Pharmaceutical Review

OCTOBER 20, 2022

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. In particular, purified water and WFI are critical when producing sterile pharmaceutical drug products. Water quality from an Annex 1 and Pharma 4.0 John Wiley & Sons, Ltd, 2010.

Food and Drug Administration 86

Food and Drug Administration Pharma Manufacturing Food 86

Contrarian Sales Techniques

FEBRUARY 26, 2023

There was an article that examine the market for generic medicines in the Malaysia, following the introduction of the first generic patent in 2010 and the introduction of generic patent law in 2012. There are some countries in the world that do not require waiting for patent expiration to produce a generic version of a drug.

Pharmaceutical 52

Pharmaceutical Medicine Government Side effects 52

World of DTC Marketing

DECEMBER 10, 2020

SUMMARY: (JAMA) The median drug wholesale list price (as defined by Average Wholesale Price) increased by 129% from 2010-2016, while median patient out-of-pocket costs increased by 53% and median insurance payments after rebates and discounts increased by 64%. The Pharma Spin. Say goodbye to all the supposed goodwill.

Insurance 181

Insurance Pharma Manufacturing Retail 181