FDA Law Blog: Biosimilars

MAY 8, 2023

a) , and related guidance documents (e.g., Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission. See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a)

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Eye on FDA

AUGUST 18, 2020

Approvals – There were 54 press statements regarding approvals so far in 2020, comparing to 42 approvals announced in 2019. The agency sent out 9 alerts during the first half of the year, 4 of which were related to COVID-19, including one for the off-label use of anti-malaria medications.

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European Pharmaceutical Review

JUNE 12, 2024

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults. 2019; 13(1):16-24. Clin Microbiol Infect.

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FDA Law Blog: Biosimilars

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 In this case, the FDA clock start date is determined as the date of receiving the submission by the Document Control Center (DCC). Attachment number) and document name or description as appropriate.

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PharmD Live

FEBRUARY 17, 2022

Acute cardiac injury has been a well-documented feature of infection with SARS-CoV-2, which causes COVID-19 among patients requiring hospitalization. Effect of aspirin on coronavirus disease 2019, Medicine: July 30, 2021 – Volume 100 – Issue 30 – p e26670 Accessed Jan. Fam Med Community Health. 2021 Apr;9(2):e000741.Retrieved

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Putting Patients First Blog

JULY 2, 2024

The NHC requests more clarity on how CMS will exclude QALY-based metrics and highlight when they have been removed from consideration in MFP justification documentation. Off-label usage often emerges from real- world clinical practice and patient experiences, which might not be reflected in the guidelines. Blendon, R., Casalino, L.,

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Drug Pricing Insurance Coverage and Processing HIPAA Labelling 52

pharmaphorum

OCTOBER 4, 2022

The final guidance follows the draft CDS software guidance issued on the same date in 2019. Additionally, relevant sources should be identified and made available to the HCP user.

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The Thyroid Pharmacist

JULY 29, 2022

Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, For sunscreens and other over-the-counter drugs, fragrances must be identified on the label. But formaldehyde has been labeled as a known human carcinogen by the U.S.

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Health and Personal Care Stores Compounding Immunity Immunization 52

The Thyroid Pharmacist

DECEMBER 7, 2022

Several years ago, after reading research about all of the toxins commonly used in flame retardants (and learning about all of the many products in my home that contain these chemicals… somewhat of a shocking list), I looked at my mattress label, only to learn it contained one of the chief offenders. Labels (Furniture, Fabrics, and Carpet).

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RX Note

FEBRUARY 23, 2023

Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Statins - Not all statins need to be taken at night.

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HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 75

Pharma in Brief

JANUARY 9, 2022

In 2019, the federal government introduced amendments to the Patented Medicines Regulations (the Amendments ). Health Canada also consulted on proposed guidelines for the use of electronic media in prescription drug labelling (see here ). b) Continued changes to the PMPRB. The FCA also provided guidance on “inventive concept”.

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The Thyroid Pharmacist

NOVEMBER 8, 2024

Between 2017 and 2019, my team and I were able to collect and analyze the data from 298 GI-MAP tests. About the Samples These 298 tests were collected from my clients and participants in the Hashimoto’s Self-Management Program between 2017 and 2019. link] Published June 27, 2019. link] Published Dec 3, 2019.

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The Thyroid Pharmacist

JANUARY 20, 2023

The first case is outlined in a 2019 report by Roberto Vita and his research team, and published in Revista da Associação Médica Brasileira. Markomanolaki and published in a 2019 issue of Journal of Molecular Biochemistry. Published 2019 Jul 22. Published 2019 Dec 9. vs. 398 U/mL). [1] Rev Assoc Med Bras (1992).

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The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition. 2019;10:864.

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