FDA Registered Manufacturers
www.acggp.com
FDA Registration is Establishments facilities that manufacture, label, package, or perform certain other operations on foods, drugs, medical devices are required to register with FDA. A&C provides the FDA registered manufacturing services in the US.
The drug approval process takes place within a framework that includes:
¡ Analysis of the target condition and available treatments ¡ Assessment of benefits and risks from clinical data. ¡ Strategies for managing risks.
Analysis of the target condition and available treatments
FDA analyzes the condition or illness for which the drug is intended and estimates the current treatment landscape which provides the context for weighing the drug’s risks and benefits. which provide the factors for weighing the drug’s risks and benefits.
Assessment of benefits and risks from clinical data
FDA evaluates clinical benefits and risk information submitted by the drug maker, taking into account any precariousness that may result from defective or incomplete data.
Strategies for managing risks
The risk management strategies included an FDA-approved drug label, which clearly describes the drug’s benefits and risks. In case, a drug maker may need to apply a Risk Management and Mitigation Strategy.
Contact Us
www.acggp.com info@acggp.com 9193902425