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Archive for the ‘Drugs’ category

Registrar Corp keeps industry up-to-date on regulations throughout the year. In 2016, the U.S. Food and Drug Administration (FDA) proposed several new regulations, including label submission requirements for certain devices, and issued extensions for compliance deadlines. Here’s a compilation of the happenings for the drug and device industries in 2016. February 18: FDA removed 771 […]

The Federal Trade Commission (FTC) recently announced a new enforcement policy for homeopathic drugs. The policy requires homeopathic drug packaging to display the following disclaimers in cases where marketers cannot adequately substantiate their claims: There is no scientific evidence that the product works. The product’s claims are based only on theories of homeopathy from the […]

The U.S. Food and Drug Administration (FDA) published its annual user fees for medical devices and generic drugs for fiscal year 2017 (October 1, 2016 through September 30, 2017). Medical Device User Fees for FY 2017 Establishment Registration Fee: $3,382 (No Reduction for Small Businesses) Premarket Application (PMA, BLA, PDP): $234,495 / $58,624 for Small […]

The U.S. Food and Drug Administration (FDA) removed 771 drug facilities from its registration database in 2016.  There were 10,505 drug facilities in FDA’s database on December 31, 2015.  As of February 17, 2016, that number had dropped to 9,734. The large decrease in registered drug facilities is likely due to facilities failing to complete […]

On February 4, 2016, the U.S. Food and Drug Administration (FDA) hosted a webinar regarding upcoming electronic filing requirements for Drug Master Files (DMFs).  FDA will require DMFs, as well as other pharmaceutical applications, to be filed in electronic common technical document (eCTD) format beginning May 5, 2017. Any paper submissions filed on or after […]

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