Overview of the FDA OTC monograph consulting services
Companies wishing to market a new product or OTC drug must file an NDA request. FDA compliance can be a lengthy process in most cases. An experienced FDA OTC monograph consulting can assist you with the filing process, compliance and complex filing. There are two regulatory guidelines for OTC drugs in the United States. They are developed under the OTC documentation process. Secondly, through the New Drug Application (NDA) process, products that do not meet the requirements of the OTC drug documentation must be approved by the NDA process.
What are the different types of our services?
Our services as FDA OTC monograph consulting include:
- Drug classification
- Labelling assistance
- OTC Drug Document Application
- A prescription for an OTC switches application.
- Preparation Time and Scope of Application (TEA) for OTC Drug Document Revisions
- Help to meet post-approval requirements
- US representative
Our consultants work with you at every step of the process and ensure timely approval and marketing of your OTC products. Our FDA-approved drug approval consultants are well versed with regulatory strategies to ensure rapid and rapid compliance with FDA requirements at every step of the approval process. We have about three decades of experience helping companies.
Our consultants have an in-depth understanding of FDA regulations, identify appropriate drug classifications (monographs or NDAs), and help prepare compliant labels based on OTC drug documentation. Our consulting services are faster and more cost-effective than other companies in this domain; for more information about the services we offer, contact us.
Urgent Steps for FDA Initiated Orders:
The FDA can begin urgent steps to issue an administrative order when:
- Drugs causing harm to public health
- Changes to drug labelling, drug class, or a combination of drugs are reasonably expected to reduce the significant or unreasonable risk of serious adverse events related to drug use.
- The FDA has issued a final, temporary order that will go into effect before the public can comment. Citizens are given at least 45 calendar days to submit comments on the last interim order. The FDA will issue its final order taking public opinion into account.
Meet the FDA:
The FDA encourages potential drug advocates and OTC drug applicants to review information available from the FDA's website related to the OTC drug review process. The FDA is developing guidelines on formal meetings between the FDA and potential sponsors or applicants to submit OMOR before the guidelines are published.
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