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US FDA Label

Advantages of US FDA label review by a third party expert

US FDA has approved certain third party companies to do a review of the US FDA label and submit the same to US FDA on behalf of the manufacturer. US FDA approves the third party reviewer who has already worked in 510K. Third-party reviewer allows client to fast track their 510 k submission reducing the time to market by 100 days on average.

As the US FDA inspects the product randomly after being marketed, if some non-conformances arise on the products are suspended from the market. So it is beneficial to provide a third-party expert review before submitting it to the client.

Third-party Expert reviews for US FDA Label also provides benefits to US FDA as they have mentioned in the guidance document on benefits of third-party reviews that they enable the FDA to use its scientific review resources for higher-risk device, while maintaining confidence in the review by third parties of low-to-moderate risk devices.

Third expert US FDA label reviews also provides benefits to consumers as they want FDA to focus on moderate to higher risk products and get as many products to the market, as soon as possible

US FDA Label Review process and timeline

Once the third-party review is forwarded to FDA, it will take approximately 30 days to make a final decision. The third-party label review involves verification of US FDA labels with respect to the requirements specific to the product.

We reviews and verifies the existing or new labels by our technical experts against the FDA labeling requirements. US FDA labelling requirements is a complex and confusing process that can include physicians, users or patients, and pharmacists. US FDA labelling requirements includes the verification of label content, claims, ingredients, format, font size and the order of declarations of information

How the drug review is conducted

USFDA will review the label template by verifying the contents and concentration of active ingredients present in the drug label as per the respective monographs. If it’s failed to get complied, the review will continue only after the manufacturer solves the non-compliance per USFDA Requirements

The review of the drug label template will be based on a detailed checklist that covers every requirement mentioned in USFDA labeling requirements. FDA will prepare a document named action points in which non-complying points of drug label template are written against the checklist and the corresponding corrections are also mentioned in the checkpoints. And FDA shall share the action point with the manufacturer

As per the corrections mentioned in the action points, we will change the existing drug label

How is the cosmetic label review conducted?

As a first step, USFDA looks and analyzes for claims in a cosmetic label. It does not accept any drug claims like treating or preventing any diseases

The second step of cosmetic label review will be checking the ingredients mentioned are as per the cosmetic ingredients dictionary and also looks for if any prohibited ingredient used or mentioned. We help the manufacturer in reviewing it, before sending it to the USFDA