Newsletter - May 19, 2022
From GMP to “EMP”: FDA to Create a Reward System for Manufacturers
When manufacturers of pharmaceutical products rise above the minimum GMP standards, they should be rewarded with fewer FDA audits, higher prices for their products, and strong support from clinical stakeholders, according to a White Paper from FDA this week. FDA believes that such manufacturers will also reduce...Read More
What Does “FDA Approved” Mean, and Who Can Use This Phrase?
The phrase “FDA Approved” is used on the labels of many products, in many cases falsely to mislead the consumers’ perception of the quality of a given product. FDA released a consumer advisory last week to list, in plain language, the regulatory processes for all the products in regulates which should be...Read More
From GMP to “EMP”: FDA to Create a Reward System for Manufacturers
When manufacturers of pharmaceutical products rise above the minimum GMP standards, they should be rewarded with fewer FDA audits, higher prices for their products, and strong support from clinical stakeholders, according to a White Paper from FDA this week. FDA believes that such manufacturers will also reduce...Read More
What Does “FDA Approved” Mean, and Who Can Use This Phrase?
The phrase “FDA Approved” is used on the labels of many products, in many cases falsely to mislead the consumers’ perception of the quality of a given product. FDA released a consumer advisory last week to list, in plain language, the regulatory processes for all the products in regulates which should be...Read More
