07/19/2019
Category: Medical device consulting
The FDA requires registered establishments to comply with Current Good Manufacturing Practices (CGMP), and there are specific regulations for each industry, such...
Read More
06/16/2019
Category: Regulatory
Human Cell, Tissue, and Cellular and Tissue-based Products (HCT/Ps) establishments are regulated under FDA’s Center of Biologics Evaluation & Research (CBER). HCT/Ps...
Read More
06/11/2019
Category: Regulatory
The biologics industry is heavily regulated with FDA’s ever-changing landscape of regulatory components. The FDA has an objective to ensure biologics companies...
Read More
05/20/2019
Category: FDA 510k consultant
Healthcare facilities consist of complex, multi-faceted work systems. The introduction of new medical devices in these systems can result in undesirable events...
Read More
05/20/2019
Category: pharmaceutical consulting firms
The ability to bring some drugs to market faster can mean life or death for some patients. The U.S. Food and Drug...
Read More
05/15/2019
Category: Medical device consulting
Errors associated with medical devices can be costly to health institutions and manufacturers, with some patients paying the ultimate price with their...
Read More
05/12/2019
Category: Research
Regulatory compliance is a significant topic among quality management personnel. In a pharmaceutical environment, failure to comply with FDA regulations can have...
Read More
03/08/2019
Category: Good Industry Practices
Every US FDA ANDA or NDA application requires time and money to develop drugs that will enter the U.S. market. Imagine spending...
Read More
02/15/2019
Category: Good Industry Practices
Pharmaceutical, medical device, and biotech companies have similar road blocks when navigating through FDA’s tough terrain. Regardless of whether a company is...
Read More
01/22/2019
Category: Good Industry Practices
The professional prescription drug labeling, such as the prescribing information (PI) or package inserts found in the PDR or at FDA websites,...
Read More
12/25/2018
Category: Good Industry Practices
The U.S. FDA is clear that medical devices and/or significant processes must be validated to ensure the standard of quality is being...
Read More
12/17/2018
Category: Good Industry Practices
For over 20 years, FDA has promoted the pursuit of increased information and the study of pharmaceutical products in pediatric patients. This...
Read More