FDA Law Blog: Biosimilars

MAY 8, 2023

a) , and related guidance documents (e.g., In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications. See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a)

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pharmaphorum

OCTOBER 30, 2022

The FDA refused to accept Y-mAbs’ first regulatory filing for the drug in 2020, but awarded the company’s second attempt a priority review earlier this year.

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Documentation Labelling Immunity Immunization 52

RX Note

JUNE 4, 2023

Cartons or bulk containers of products/cosmetics should be adequately labelled with at least the product name, batch number and where necessary, expiry data or retest date. For all suppliers, a document (e.g. External Links Guideline on Good Distribution Practice, 2018 Garis Panduan Pengurusan Farmasi Logistik, 2020

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pharmaphorum

DECEMBER 14, 2022

The top-line result wasn’t backed up by overall mortality data however, viewed as being crucial to the take-up of the drug if approved, and Amgen ducked out of the alliance shortly after the results were made public towards the end of 2020. There was also no impact on quality-of-life measures.

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Documentation Labelling 52

European Pharmaceutical Review

DECEMBER 20, 2023

1 The changes form part of the 2020 Pharmaceutical Strategy for Europe will impact pharma and biopharma companies operating in Europe. In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents. analysis (Source: L.E.K)

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Biosimilars Labelling Documentation 98

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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Documentation Packaging Communication Labelling 75

GMPSOP

JUNE 28, 2024

Additional documents included each month. Packaging/labeling/Misbranding: 41 warnings vi. In 2019 and 2020, warning letters were issued for “Adulterated Food and Supplements” at 36% and 33%, respectively. Similarly, the packaging, labeling, and misbranding-related warning letters were the top reasons in 2019.

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Documentation Packaging Labelling Pharmaceutical Manufacturing 59

Pharma in Brief

JANUARY 9, 2022

In response to the COVID-19 pandemic, in 2020, the Minister of Health signed interim orders designed to streamline the process to authorize the importation or sale of drugs, vaccines, and medical devices used to diagnose, treat, mitigate, or prevent COVID-19. Major Policy Initiatives. (a) a) COVID-19.

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Documentation Labelling Vaccines Packaging 52

European Pharmaceutical Review

JULY 4, 2024

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. Premier Consulting [Internet]. 2018 [cited 2024May].

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Drug Development Biosimilars Documentation Labelling 103

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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Health and Personal Care Stores Labelling Immunity Immunization 80

LifeProNow

APRIL 9, 2023

These sNDAs are supported by results from the PHAROS trial ( NCT03915951 ), an open-label, multicenter, non-randomized, Phase 2 study (n=98) to determine the safety, tolerability, and efficacy of BRAFTOVI given in combination with MEKTOVI in patients with BRAF V600E-mutant metastatic NSCLC.

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Adverse Reactions Labelling Documentation 100

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. Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial,The Lancet, Volume 399, Issue 10320, 2022, Pages 143-151,ISSN 0140-6736.

Hospitals 52

Hospitals Diabetes Documentation Labelling 52

Proxsys Rx

MAY 3, 2023

Consider the implications for the average 340B-eligible patient According to a 2020 drug trend report , specialty drugs were used by less than 2% of the population. We handle the rest of the process — painstakingly documenting everything we do, and reporting back to the health systems at every critical step.

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Specialty Pharmacies Hospitals Documentation Labelling 52

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. hstc=117268889.c6acac5669d4f1e6063a774e6d96c6b5.1716560813145.1716560813145.1716560813145.1&

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Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

Pharma in Brief

JANUARY 17, 2021

The Court found that the prior art documents cited by Pharmascience ( Pinchasi 2007 and Karussis 2006 ) neither disclosed nor enabled the asserted claims of the 437 Patent. The Court rejected Pharmascience’s argument that the skilled person could have easily prescribed Copaxone ® 20 mg for the claimed use, though off-label.

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Dosage Documentation Labelling 52

The Thyroid Pharmacist

JULY 29, 2022

I was inspired to write this blog after the September 2020 Cameron Peak fires in Colorado. 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.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunity Immunization 52

The Thyroid Pharmacist

JULY 14, 2023

12] In another study that was just published in 2020 by Ercetin and colleagues, 350 patients with Hashimoto’s were studied! 25] However, a 2020 study of 350 people done by Ercetin and colleagues, actually used iron, selenium, and vitamin D, and still got impressive results. 2020; 38(7): 409-412. 2010;20(10):1187-1190.

Dosage 98

Dosage Immunity Immunization Documentation 98

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.

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

FDA Law Blog: Biosimilars

JULY 9, 2024

Procedures for Submitting the DAP Sponsors should describe the DAP clearly and concisely, with limited cross-referencing to previously submitted documents. Would any such failure to meet DAP goals be reflected in labeling? 510(k) submission, De Novo classification request, Premarket Approval (“PMA”) application).

Drug Development 59

Drug Development Communication Documentation Labelling 59

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Gilenya is an oral medication for multiple sclerosis.

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Documentation Hospitals Dosage Drug Pricing 97

The Thyroid Pharmacist

JANUARY 20, 2023

Please consider the following and be sure to read the precautions on individual labels before you try a new herb, supplement, or blend. (In Holy Basil ( Ocimum sanctum ) The anti-inflammatory effects of holy basil (also known as tulsi) have been documented in many in vitro and in vivo studies. Published 2020 Jun 9. 2020;11:850.

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HIV Treatment and Prevention Agents Diabetes Immunity Immunization 98

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. Endocr Rev.

Dosage 98

Dosage Documentation Diabetes Labelling 98

RX Note

FEBRUARY 9, 2025

Labelling format Generic name of medication Name of manufacturer or distributor Dosage form, including special designations (e.g. Repackage only one medication at a time Prepare only the number of labels that will be needed for the repackaging run. Do not prepare extra labels.

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Packaging Labelling Dosage Documentation 40

FDA Law Blog: Biosimilars

JANUARY 2, 2025

In contrast, the 2022 proposed redefinition focused on food groups recommended by nutrition science and the Dietary Guidelines (DGs), 2020-2025. Under the proposed rule, any raw whole fruits and vegetables could be labeled healthy no matter the level of added sugars, sodium, or saturated fat.

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Labelling Documentation 52

FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days. Sometimes, though, there is no clear precedent, and the product’s regulatory status falls into an undiscovered country.

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Documentation Labelling 69

Ramblings of a pharmacist

OCTOBER 26, 2022

In July 2020, a pharmacy in Brawley, CA was attempting to obtain Biktarvy® for their patients at a price that would sustain the pharmacy practice – i.e. a price that is less than the insurance’s allowed amount. The result of this will absolutely be that counterfeit medications WILL make their way into the drug supply chain.

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Documentation Labelling Independent Pharmacies Community Pharmacies 40

The Thyroid Pharmacist

NOVEMBER 8, 2024

1] Additionally, in 2020, a study was published that also ties the eradication of Blasto to improvement in Hashimoto’s, including a reduction in TSH and TPO, as well as a decrease in a particular pro-inflammatory cytokine (IL-17) thought to have a role in Hashimoto’s pathogenesis. [2] Published 2020 Feb 21. Accessed August 6, 2020. [6]

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Immunity Immunization Diabetes Adverse Reactions 72