The Food and Drug Administration (FDA) is expected to make several decisions this year that will impact many Americans.
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The FDA is not only expected to have a new commissioner this year, it is expected to make many important decisions.
Some issues that the FDA is expected to confront include:
- E-cigarettes – The FDA’s proposal will extend the agency’s authority to regulate e-cigarettes. The “deeming rule” will also likely require a pre-market review of devices to determine whether they are safe. Further, the FDA is expected to ban sales to minors and require labels stating that e-cigarettes contain nicotine.
- Drug Marketing – The FDA is revising its own rules after a decision last summer that allowed a fish oil company to give doctors truthful, scientific information on unapproved uses for its drug. Before that decision, drug companies had to prove that their products were safe and effective to treat a specific disease before they could be marketed for that purpose. The FDA is now dealing with the ramifications of the decision.
- Generic Drugs – The FDA has over 4,300 applications awaiting approval for generic drugs. The FDA said many applications are deficient, however, this year they are expected to tackle the outstanding applications. The FDA also is expected to finalize a rule that would let generic companies update their labels without FDA approval.
The FDA will have other challenges this year that will impact many, however these are the largest topics on the agenda.
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