FDAbasics Blog
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FDAbasics LLC, previously known as Tobias Systems, started in 1995. The initial focus was on FDA US Agent services to numerous foreign companies for selling medical devices, drugs, and food products in the United States. Our focus is on providing you with the advice you need, not just for regulatory consulting but for your long-term business goals. We pride ourselves in offering expert,..
FDAbasics Blog
1M ago
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) significantly changes cosmetic product regulations. Let's delve into its impact on the cosmetic industry: Expanded ..read more
FDAbasics Blog
6M ago
What is MoCRA Registration FDA MoCRA registration is the new requirement as per the Cosmetic Modernization Act. As per MoCRA the manufacturer of the cosmetic products must ..read more
FDAbasics Blog
9M ago
What is an FDA MoCRA for cosmetics? MOCRA stands for Modernization of Cosmetics Regulation Act of 2022, a new regulation being implemented by the FDA in 2023 for cosmetic ..read more
FDAbasics Blog
1y ago
FDA has published the FY 2023 for medical device registration for FY 2023. The FDA fee for medical device registration for FY 2023 is $ 6943. Who has to pay the medical device ..read more
FDAbasics Blog
1y ago
Have you received the email from FDA with NOTICE OF INTENT TO INACTIVATE OUTDATED DRUG LISTING RECORDS? Here is the detailed action plan for you. FDA has started sending ..read more
FDAbasics Blog
1y ago
The Food and Drug Administration (FDA) requires reports on the amount of each listed drug annually manufactured, prepared, propagated, compounded, or processed for commercial ..read more
FDAbasics Blog
1y ago
FDA has published the OTC monograph facility fees for FY 2022. There is about a 19 % increase in the fee structure compared to FY 2021. Facility Type FY 2022 ..read more