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Prikvačeni tweet
Well, it's
#healthpolicyvalentines day, which means it's time to repost THE GREATEST FDA WARNING LETTER EVER. Ahem: Roses are red, Violets are blue, Your product is made with "Love," yes, a ton, But that's a labeling violation under 21 CFR 101.4(a)(1) https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm577393.htm …pic.twitter.com/V9y5mNKB5f
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I cannot for the life of me understand why HHS declared a Public Health Emergency last week, and then waited until today to issue the PHE authorizing emergency use of medical products. Not sure it made a difference in timing, but still.https://www.fda.gov/news-events/press-announcements/fda-takes-significant-step-coronavirus-response-efforts-issues-emergency-use-authorization-first …
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Amid record approvals, the FDA just established recommendations for how companies can promote biosimilar products--and how biologics companies *can't* disparage biosimilars. Tons of interesting nuggets within. For AgencyIQ subscribers: https://fda.agencyiq.com/article/00000170-0ca7-dc4f-a1f2-2ef7dc980000 …
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In non-Pandemic news, the FDA has received record interest in botanical drug development (56 INDs in 2018 alone), but has only approved 2 botanical drugs in the last 15 years. Why? Lots of interesting reasons. I analyze for AgencyIQ subscribers here: https://fda.agencyiq.com/article/0000016f-fd19-dc4f-a1ef-ff59934f0000 …
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CORRECTION: Based on some sharper eyes than mine, my take isn't correct. HHS actually needs to issue *an additional* declaration before an EUA may be issued by the FDA. It seems likely, but it's not immediate. I regret the error. Page 17/18" https://www.fda.gov/media/111302/download …https://twitter.com/AlecGaffney/status/1223352271779614722 …
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It's also really significant to me that this declaration doesn't use HHS's "significant potential" authority for a Public Health Emergency. It's a full Public Health Emergency. To me, that indicates that HHS missed an opportunity to address this earlier.
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Also interesting about this public health emergency declaration is the language. Declares the public emergency retroactive to the 27th. https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx …
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What does this mean for life sciences companies? The FDA can now issue Emergency Use Authorization (EUAs). That allows investigational products to be marketed more quickly for nCoV2020. The main beneficiary will probably be diagnostic companies. (https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization …)https://twitter.com/SecAzar/status/1223346974264561665 …
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Alexander Gaffney proslijedio/la je Tweet
A trio of FDA guidance documents has established a framework for assessing gene therapies for rare diseases, including hemophilia and retinal disease. AgencyIQ has a deep dive into the guidance, industry comments and impacts for subscribers: https://fda.agencyiq.com/article/0000016f-fc06-d7e2-a76f-ff9707600000 …
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Alexander Gaffney proslijedio/la je Tweet
Trump health chief tries to contain coronavirus — and White House frustration via
@nancook@ddiamond https://politi.co/31aocVv#coronavirusHvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
The WHO's declaration of a public health emergency could put pressure on HHS to make a similar declaration. AgencyIQ has published extensive analysis on why a PHE declaration matters for the FDA in particular: For subscribers: https://fda.agencyiq.com/article/0000016f-ecb5-dc4b-a3ff-eebf69b70000 … https://fda.agencyiq.com/article/0000016f-cabe-df03-a1ff-ffbe898b0000 …
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Amid a surge in oncology drug ads, the FDA wants to know: Do viewers understand cancer terminology? Some new studies could help mold a new DTC approach for more than just cancer drugs. AgencyIQ's analysis for subscribers: https://fda.agencyiq.com/article/0000016f-f6cc-d7e2-a76f-ffdf38a40000 …
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The FDA's newest web tool for PEPFAR information is generally useful, but either this data is wrong, or this is the most ridiculously weird baseline I have ever seen in my life. 220: [-----] 2: [----] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=pepfar.page …pic.twitter.com/2YQ7hsgBXm
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(And more analysis on the way, as we read through the FDA's Novel-length set of guidance documents. Guns, Germs and Steel; meet Genes, Editing and Orphans.)
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Yesterday, the FDA unveiled what 21 CFR defines as a "metric ton of guidance documents" on gene therapy. AgencyIQ has been digging in deep. Our take on: Replication-competent virus testing: https://fda.agencyiq.com/article/0000016f-f1fa-d7e2-a76f-fffbac4c0000 … Orphan designation and "sameness": https://fda.agencyiq.com/article/0000016f-ee86-dc4f-a1ef-eed614bd0000 …
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Interestingly, the FDA may face additional (legal) challenges here. A recent citizen petition by Vifor contends the FDA lacks authority to approve complex generics as ANDAs: https://www.regulations.gov/document?D=FDA-2020-P-0158-0001 … AgencyIQ analysis here: https://fda.agencyiq.com/article/0000016f-a5f2-d64c-a9ff-f5fa5ea90000 …https://twitter.com/ScottGottliebMD/status/1222533108341313536 …
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Just throwing this out there to the regulatory intelligence professionals: Has anyone else not been getting emails from the Federal Register's Public Inspection service at the usual times? Like the items are new on the website, but I didn't get the normal emails.
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What does the FDA's newest draft guidance document on gene therapies and the orphan drug act mean for development of gene therapies?
@lauradiang unpacks the regulatory background, latest developments and potential impact for AgencyIQ. For subscribers: https://fda.agencyiq.com/article/0000016f-ee86-dc4f-a1ef-eed614bd0000 …Hvala. Twitter će to iskoristiti za poboljšanje vaše vremenske crte. PoništiPoništi -
Interesting approach from the dietary supplement trade group NPA. The FDA found lots of bad actors when there was an outbreak of Ebola, and wound up sending lots of Warning Letters. https://www.washingtonpost.com/news/to-your-health/wp/2014/09/24/fda-warns-three-companies-against-marketing-their-products-as-ebola-treatments-or-cures/ … (Some big companies, too: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gojo-industries-inc-599132-01172020 …)https://twitter.com/DrFabricant/status/1222250389023662081 …
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Interesting use of the word "potential" here. HHS has the legal authority to declare a Public Health Emergency based on "potential" scenarios. And it has previously, such as in the case of MERS-CoV. https://www.phe.gov/emergency/news/healthactions/phe/Pages/mers-cov.aspx … https://twitter.com/AndrewE_Dunn/status/1222192391429509122 …pic.twitter.com/4v5oVPuLy6
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We're already working on some other analyses exploring gaps in the FDA's legal and regulatory authority to address coronavirus. Have any tips or insights to add? My inbox is open. agaffney at agencyiq
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