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...
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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...
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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...
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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,...
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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...
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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...
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12/03/2018
Category: Good Industry Practices
Quality is key to any successful business. Quality ensures standards are being met in processes or products. Companies involved in pharmaceuticals, biologics,...
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11/29/2018
Category: Good Industry Practices
During BRG project meetings, we engage in decision-making as well as philosophical discussions that cross a number of epidemiological topics. These often...
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08/31/2018
Category: Good Industry Practices
Outside the pharmaceutical world, the concept of “Pharmacovigilance” is rarely discussed or understood. In certain circumstances, the full conduct of pharmacovigilance may...
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08/29/2018
Category: Good Industry Practices
A literature review can be used to strengthen a human drug, biologic, or medical device product portfolio and their corresponding regulatory submissions....
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07/29/2018
Category: Regulatory
Establishment Registration and Product Listings Before discussion of the role of the FDA U.S. Agent, it is useful to understand Establishment Registrations...
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