REGULATORY PILLS - Part IV:
Is It Really 'FDA Approved'?
The #FDA is responsible for protecting #publichealth by regulating #humandrugs and #biologicalproducts, #animaldrugs, #medicaldevices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation.
But not all those products undergo #premarketapproval — that is, a review of #safety, #quality, and #effectiveness by FDA experts and agency approval before a product can be sold to consumers.
Even when FDA approval is not required before a product is sold, the agency has legal #regulatoryauthority to act when safety issues arise.
What is #FDAApproval?
According to the FDA website,
“FDA approval of a drug means that data on the drug’s effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.”
#CDER stands for the FDA’s Center for Drug Evaluation and Research.
This branch focuses solely on evaluating new drugs.
The Approval Process
There are three steps to the #FDAapprovalprocess.
1. The Target Condition and Available Treatments
FDA reviewers evaluate the target condition to determine how dangerous the disease is, and they weigh that against the risk/reward of the proposed drug.
2. Benefits and Risks of the Proposed Medication
After the reviewers look at the overall situation, it is now time to assess the benefit and risk information sent by the drugmaker.
It is the drug maker’s responsibility to submit two well-designed #clinicaltrials, “to be sure that the findings from the first trial are not the result of chance or bias.”
3. Risk Management Strategies
Finally, the FDA devises strategies for managing the risks of the proposed drug.
Every drug on the market has some level of #risk, and it is up to the FDA to determine those.
In some cases, it is up to the manufacturers to create a Risk Management and Mitigation Strategy (#REMS).
FDA Approval of Drug Products
Whether or not a new drug product requires FDA approval depends on whether the new drug conforms to an over-the-counter (#OTC) monograph.
Once an OTC monograph is final, drug establishments can market OTC drugs that conform to the monograph without FDA approval.
If a new drug does not comply with a monograph, it will require FDA approval.
Though FDA approves new drugs, the agency does not approve compounded drugs.
FDA Approval of Medical Devices
FDA places #medicaldevices into one of three risk-based categories:
Class I, Class II, and Class III.
Class I and II devices do not require FDA approval.
Drug and Medical Devices establishments must register with FDA and list their products, but neither registration nor listing indicates FDA approval of the establishment or its products.
If you like this post follow me on LinkedIn
#regulatory
CEO/FOUNDER
9moKadınların basaramayacağı iş yok! Yeter ki önyargılarla engelleyenler olmasın! Tebrikler👏👏👏