Gain market share with your OTC drug products while meeting FDA regulations
Getting drug products approved is a complex process. In many cases, OTC drugs need to be approved by the FDA before they are marketed. However, there are some exceptions.
If your products comply with the FDA’s OTC monograph regulations, you don’t need any FDA approval before marketing your products. However, they do need to be registered and listed with the FDA.
The OTC monograph is a “recipe book” outlining which ingredients can be used and how. If you meet these requirements, then the drugs are classified as GRASE, which stands for “generally recognized as safe and effective.”
If you sell homeopathic drugs, keep in mind that if they meet the new Compliance Policy Guide regulations, you don’t need FDA approval before marketing. However, the products will still need to be registered and listed with the FDA.
At FDA Atty, we have extensive experience helping our global clients navigate the complicated FDA regulations around OTC and homeopathic drugs. Here’s how we can help:
Label and advertising review: We offer regulatory counseling to determine whether your product needs prior approval before marketing. Plus, we review labels and product packaging, in addition to marketing materials like ads, websites, and point-of-sale material, to ensure it’s all in compliance with FDA regulations.
Classification review: Confused on whether a product is a cosmetic, drug, or both? Wondering if an FDA monograph applies? FDA Atty can guide you to the right answers through a classification review.
Adverse event reporting and record keeping: If there have been any adverse events related to your drug products, you’re required to report them to the FDA. We help clients develop standard operating procedures so you can easily identify and report the events, train your staff, and maintain compliance.
Export certificates: With all of the different export forms you need, how do you know you’ve got the right ones? As specialists in FDA regulation, we can help you identify the right forms, fill them out correctly, and ensure that your drug products don’t cause any issues at the border.
Feel confident knowing you’ve got an FDA expert on your side, looking out for your business. Click the button below to contact FDA Atty and start the process.
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Expert knowledge of FDA regulations that helps you strategically grow your business
We retained Marc to answer some extremely time-sensitive and complex questions regarding COVID-19 and FDA regulations. Despite being overloaded with clients, Marc was very responsive and was able to provide us with the comprehensive answers we needed within 24 hours. This enabled us to respond quickly and effectively to the changing regulatory landscape. I strongly recommend using Marc and look forward to working together again in the future.
I am truly impressed… Marc understands the workings of the regulatory agencies and this allows him to very effectively achieve the results that his customers want without creating an environment of confrontation. Beyond that, he has insight into the laws governing foods, supplements, and medicine that goes beyond that of the federal officials involved in these regulatory areas. This allows him to open avenues of compromise and agreement that would not have existed before he was brought to bear on the difficulty. Even as he produces compromise and agreement, it is clear that he holds his customer's interest at heart.
I have never found a more powerful and effective counsel.
Steven Frank CEO
Nature's Rite Remedies
Marc Sanchez has provided our company with expert advice and letters that have saved us time and money in dealing with the FDA. We have worked with many FDA attorneys and consultants in the past and they can't hold a candle to the knowledge and expertise that we have found with Marc.
Jeff Maier (VP Sales & Marketing)
Marc is incredibly intelligent, poised and able to make reasonable, timely recommendations about risk. Additionally, he is extremely organized, has a calm demeanor and has provided insightful counsel to me on many regulatory issues. I strongly recommend him.