eyeonfda

@eyeonfda

Author of the blog Eye on FDA -

Washington, D.C.
Vrijeme pridruživanja: travanj 2008.

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  1. prije 15 sati

    finalizes the draft guidance entitled “Recommendations for Re-qualification of Blood Donors Deferred Because of Reactive Test Results for Antibodies to Human T-Lymphotropic Virus Types I and II (anti-HTLV-I/II)

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  2. proslijedio/la je Tweet
    3. velj

    Patients widely received antibiotics with no record of seeing a doctor, a nationwide study found, despite recommendations that doctors physically screen patients to prevent unnecessary prescriptions that could contribute to superbugs, reports

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  3. 4. velj

    to study Health Care Provider ( ) understanding of the practices respecting products - specifically understanding of various Abuse Deterrent Properties ( ) -

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  4. 4. velj

    Timely given the current public health concerns - to hold Non-Prescription Drug Advisory Committee ( ) meeting to discuss input from its request for information on Food Handler Antiseptic OTC Drug Products - to be on 3/11/2020 -

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  5. 3. velj

    / stops administration of vaccinations in its HVTN 702 clinical trial of an investigational HIV vaccine after interim review reveals that the regimen did not prevent -

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  6. 3. velj

    and announce public workshop for March 9, 2020, on a Competitive Marketplace for -

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  7. 3. velj

    makes available draft guidance - Promotional Labeling and Advertising - Considerations for RX Biological Reference and Biosimilar Products--Questions and Answers -

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  8. proslijedio/la je Tweet
    31. sij

    Flavored e-cigs, in kid-friendly flavors like Unicorn, Cherry Crush and Icy Pineapple, are permitted for sale if they are "disposable." Meet the new Juul.

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  9. 31. sij

    Well. That's timely.... announces the renewal of the and Related Biological Products Advisory Committee -

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  10. 28. sij

    issues guidance docs to provide clarity for product developers of gene therapy products -

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  11. 28. sij

    to study indications as presented in -

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  12. 23. sij

    sets 2/26 meeting of Oncologic Drugs Advisory Committee to discuss NDA for (AM) and sBLA for metastatic non-small cell lung cancer -

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  13. 23. sij

    AdComms were down, approvals were not - my 2019 look-back at Advisory Committee meetings held - how many approvals, how many not, how many disagreements w/FDA?

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  14. 22. sij

    House Oversight and Investigations Subcommittee to hold hearings on e-cigarette use in the U.S. on Wednesday, February 5 with testimony from leading manufacturers - -cigs -cigarettes

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  15. 21. sij
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  16. 16. sij

    sent out letters this year - both Warning and Untitled - Here is an overview of 2019 enforcement related to pharmaceutical company marketing and communications -

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  17. 15. sij

    issues draft guidance - Pediatric Study Plans for Oncology Drugs: Questions and Answers -

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  18. 14. sij

    There were a lot of factors that went into media coverage this year about pharma pricing, but the big player this year besides Congress was ICER -

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  19. proslijedio/la je Tweet
    13. sij

    Debate about drug prices isn't going away, but what does the media conversation look like & who's doing the talking? and I analyzed news coverage from outlets including for a report. Read it here:

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