The Most Important Compliance Best Practices You Need to Know

When it comes to immunogenicity testing of biotech products and derivatives, a number of risk factors have to be considered. This article describes these risk factors and who should consider them during the testing process.

The FDA has published a guidance document detailing which studies should be included in the clinical studies section of prescription drug labeling, how individual studies should be described, and what data should be presented. The guidance aims at making the clinical section labeling more useful, helping promote consistency in content and format across various drug product classes and indications.

This article describes the best practices to comply with the recommendations in this guidance.

The FDA-prescribed adverse reactions section makes it easier for healthcare practitioners to identify adverse reactions that are most important for prescribing decisions. This article gives the best practices for complying with the adverse reactions section of labeling for human prescription drug and biological products.

A vaccine is a biological preparation that provides immunity against a particular disease. It is usually made of dead or weakened organisms which cause the particular disease. Biosafety means the safe handling of infectious biological materials which can cause diseases. Biosafety level refers to safety tiers prescribed by the Center for Disease Control (CDC), a United States Federal Agency, for laboratories which work with infectious materials. 

This article discusses how to comply with biosafety risk assessment requirements during vaccine production.

Department of Biotechnology (DBT) under the National Biotechnology Strategy has recommended the establishment of National Biotechnology Regulatory Authority. NBRA would consist of two wings:

• One dealing with food and agriculture biotechnology
• Another dealing with medical and pharmaceutical biotechnology

Prof. M. S. Swaminathan report recommends that NBRA can work in instilling public, political, professional and commercial confidence in the science. It aims to protect the health of people and environment by assessing risks and preventing those risks by regulating safe development and deployment of biotechnology products and processes.

U. S. Department of Agriculture’s newly proposed rule governing genetically engineered crops, including food crops engineered to produce pharmaceutical and industrial products came under severe opposition by the Union of concerned scientists. The charge is that the rule does not protect the U. S. food supply from contamination by drugs from “pharma” crops. There seems to be a contamination by way of cross-pollination or seed mixing between pharma food crops and crops intended for consumption.

Recommendations from various like minded organizations such as UCS and Grocery Manufacturers Association to ban outdoor production of pharma food crops have been ignored by USDA. The new proposal also does not offer any incentives for pharma companies to follow already existing safer methods of producing drugs.

USDA has also left a very small window for public participation in its rush to enact this rule into law.