We’ve added a comprehensive FDA Handbook to our website to help you better understand FDA rules, compliance expectations, and…
FDA Investigator’s Manual
We’ve added a comprehensive FDA Handbook to our website to help you better understand FDA rules, compliance expectations, and…
Apr, Mon, 2025
Analytical Testing Outsourcing: Growth Trends & Outlook
CDMOs and CROs weigh in on today’s analytical testing outsourcing trends, including growth trends, challenges and more. Analytical laboratory…
Analytical Testing Outsourcing: Growth Trends & Outlook
CDMOs and CROs weigh in on today’s analytical testing outsourcing trends, including growth trends, challenges and more. Analytical laboratory…
Jul, Wed, 2024
A Comparative Metagenomic Analysis of Specified Microorganisms in Groundwater for Non-Sterilized Pharmaceutical Products
Abstract In pharmaceutical manufacturing, ensuring product safety involves the detection and identification of microorganisms with human pathogenic potential, including Burkholderia…
A Comparative Metagenomic Analysis of Specified Microorganisms in Groundwater for Non-Sterilized Pharmaceutical Products
Abstract In pharmaceutical manufacturing, ensuring product safety involves the detection and identification of microorganisms with human pathogenic potential, including Burkholderia…
Jan, Wed, 2021
Pharmaceutical Supply Chain Infiltrated with Methanol
According to FDA, the pharmaceutical supply chain has been penetrated with ethanol that is contaminated and sometimes substituted with methanol.
Pharmaceutical Supply Chain Infiltrated with Methanol
According to FDA, the pharmaceutical supply chain has been penetrated with ethanol that is contaminated and sometimes substituted with methanol.
Nov, Fri, 2020
FDA Finalizes Insanitary Conditions Guidance for Compounding Facilities
The FDA has issued a statement with further emphasis on its intentions to increase enforcement against Insanitary conditions at compounding facilities.
FDA Finalizes Insanitary Conditions Guidance for Compounding Facilities
The FDA has issued a statement with further emphasis on its intentions to increase enforcement against Insanitary conditions at compounding facilities.
Oct, Wed, 2020
What Do FDA Investigators Look For At Compounding Facilities?
Recent FDA-483’s and Warning Letters reveal patterns of common observations by the FDA at compounding facilities.
What Do FDA Investigators Look For At Compounding Facilities?
Recent FDA-483’s and Warning Letters reveal patterns of common observations by the FDA at compounding facilities.
Jul, Wed, 2020
Dexamethasone Sodium Phosphate Added to the List of Drugs for Temporary Compounding
The FDA has added Dexamethasone Sodium Phosphate to the list of drugs for temporary compounding by outsourcing facilities and…
Dexamethasone Sodium Phosphate Added to the List of Drugs for Temporary Compounding
The FDA has added Dexamethasone Sodium Phosphate to the list of drugs for temporary compounding by outsourcing facilities and…
May, Thu, 2020
FDA Updates Guidance On Adverse Reporting During a Pandemic
The FDA made an update to their final guidance, “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements…
FDA Updates Guidance On Adverse Reporting During a Pandemic
The FDA made an update to their final guidance, “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements…
May, Fri, 2020
Updates to FDA’s Purple Book: Database of Licensed Biological Products
This week the FDA updated the Purple Book: Database of FDA-Licensed Biological Products. The update is part of a…
Updates to FDA’s Purple Book: Database of Licensed Biological Products
This week the FDA updated the Purple Book: Database of FDA-Licensed Biological Products. The update is part of a…
May, Fri, 2020
FDA Announces Update on MOU for Compounding Pharmacies
On May 13, a standard memorandum of understanding, also known as a MOU, between the FDA and the states…
FDA Announces Update on MOU for Compounding Pharmacies
On May 13, a standard memorandum of understanding, also known as a MOU, between the FDA and the states…