FDA News Update

HPHC

HPHC or Harmful and Potentially Harmful Constituents is a submission required under the 2016 Deeming Regulation. By November 8, 2019, vape (e-liquids and hardware), hookah…

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Redacting a FOIA Request

Redacting a FOIA Request – Tips & Insights The Freedom of Information Act Amendments of 1996 (FOIA). FOIA allows members of the public to request…

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FDA Approved Meaning

FDA Approved Meaning One of the most frequently asked questions by clients and the public alike is what FDA approved means. The difficulty is there…

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FDA Due Dilligenc​e Review

FDA Due Diligence Review Congratulations, you sold or are planning to sell your company. Whether that’s a medical device, drug, food, dietary supplement or cosmetic…

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FDA Shutdown

FDA Shutdown The partial government shutdown, now in its 24th day with impacts at the FDA felt across all its Centers. Currently, with the FDA shutdown,…

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CBD

Cannabidiol or CBD, is a common ingredient seen in a lot of products, especially dietary supplements. But what is the regulatory status of CBD? This…

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Hemp GRAS

The FDA recognized Hemp as GRAS today. The FDA Atty law firm worked with Fresh Hemp Foods Ltd. (Manitoba Harvest) to file GRN 000765, GRN…

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Microneedling 510(k)

Microneedling 510(k) The first microneedling 510(k) has been filed following the formal issuance of the Microneedling Classification Order this summer (link to Classification Order here). The…

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Microneedling Update

Microneedling Update The FDA formally issued a Microneedling Classification Order on Friday (link here). Unlike before, the Final Order is now codified in the Code of Federal…

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FDA FSVP

FDA FSVP FDA FSVP and FSMA Enforcement Update Marc recently attended the Food and Drug Law Annual conference as a speaker alongside FDA’s interim director…

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Microneedling Classification Order

Microneedling Classification Order The FDA issued a Microneedling Classification Order that will fundamentally reshape how microneedling devices are sold and used. The classification order (link here) was…

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Government Shutdown

Government Shutdown A government shutdown now seems increasingly likely (see, Reuters latest headline). This blog wrote extensively on the 2013 Government shutdown (here, here, and…

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