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.

Documentation 75

Documentation Packaging Communication Labelling 75

FDA Law Blog: Biosimilars

JULY 6, 2023

In fact, the priority designation for the final rule is labeled as “economically significant.” Finally, CDRH would need to ensure alignment on existing guidance documents and regulations that refer to the QSR or 21 C.F.R. Dr. Shuren further elaborated that he hopes the final rule will be “out by the end of this year.”

Documentation 52

Documentation Labelling 52

Eye on FDA

JANUARY 9, 2022

As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist.

Communication 64

Communication Documentation Labelling Pharmaceutical Companies 64

pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.

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Documentation Labelling Communication 95

FDA Law Blog: Biosimilars

JANUARY 1, 2024

We are unable to determine whether the number of such Warning Letters issued during the entire year represents a significant increase over 2022. The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Terragene S.A.,

Documentation 59

Documentation Labelling 59

pharmaphorum

MARCH 26, 2021

The GMP provisions require the EU and UK to recognise the other’s manufacturing facility inspections and accept its GMP documents. The sizeable gap in the TCA is the EU and UK’s failure to agree on mutual recognition of conformity assessments, approval bodies, product markings or labelling, other than the very limited provisions on GMP.

Documentation 96

Documentation Labelling 96

European Pharmaceutical Review

JULY 20, 2023

On 14 July 2022, the European Commission published a proposal for a regulation on substances of human origin (SoHO) intended for human application. Next steps The public consultation period ended on 8 September 2022 and feedback provided is currently being assessed by the European legislator. Cited 2023Mar].

Labelling 75

Labelling Documentation Hospitals 75

pharmaphorum

OCTOBER 27, 2022

The rationale for engaging with certain influencers and digital opinion leaders should be considered and documented. It is imperative to assess the risks of undue influence on HCPs, patients, and vulnerable groups, and of their use being perceived as improper promotion.

Communication 87

Communication Pharmaceutical Manufacturing Packaging Documentation 87

FDA Law Blog: Biosimilars

MAY 19, 2023

Serial testing was defined as testing symptomatic individuals twice over three days with at least 48 hours between tests, which is in accordance with study findings from the National Institute of Health referenced here and current EUA labeling for serial testing. Customer Support Help line).

Labelling 40

Labelling Documentation 40

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. 4, 2022 [link]. One area of concern for both health care providers and their patients is the long-term effect of COVID-19 infection on patients with chronic diseases. Bibliography.

Hospitals 52

Hospitals Diabetes Documentation Labelling 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. 2022 [cited 2024May]. 1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. researchspace.auckland.ac.nz.

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

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.

Documentation 69

Documentation Labelling 69

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

It finalized a draft guidance published in 2022. Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.”

Packaging 59

Packaging Documentation Labelling Communication 59

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., and Keating, N.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing HIPAA Labelling 52

Putting Patients First Blog

SEPTEMBER 3, 2024

Manufacturer-Focused Input Question 30: Off-Label Use. CMS has appropriately highlighted the significance of off- label use information, providing a specific avenue for manufacturers to submit data on off-label uses supported by evidence-based guidelines listed in CMS-recognized Part D compendia. and Keating, N.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling Communication 52

Pharmaceutical Technology

SEPTEMBER 7, 2022

AEs can be caused by using medicinal products within or outside the terms of their marketing authorisations (such as off-label therapeutic use, overdose, misuse, abuse or medication errors), as well as from occupational exposure. The following is adapted from a presentation given by Dave Par é and Silvio Scozzari at the DIA 2022 conference.

Data Entry 52

Data Entry Vaccines Documentation Labelling 52

PharmaShots

JUNE 1, 2023

We are conducting an open-label, dose-escalation, phase I/II study PDC-LUNG-101 assessing the safety, tolerability, immunogenicity, and the preliminary clinical activity of therapeutic cancer vaccine PDC*lung, associated or not with anti-PD1 treatment in patients with non-small-cell lung cancer (NSCLC).

Immunization 40

Immunization Immunity Vaccines Health and Personal Care Stores 40

The Thyroid Pharmacist

JULY 14, 2023

I was excited to see a review article published in 2022, that concludes: “Besides current treatment strategies, LLLT could be a promising therapeutic approach for the treatment of AIT [autoimmune thyroid disease].” [14] Individual doctors may still be able to utilize this therapy with their patients as an “off-label” use. 2022;13:e34.

Dosage 98

Dosage Immunity Immunization Documentation 98

Proxsys Rx

MAY 3, 2023

We published that post in September, 2022. We handle the rest of the process — painstakingly documenting everything we do, and reporting back to the health systems at every critical step. Fortunately, those steps tend to be the least burdensome in the process.

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Specialty Pharmacies Hospitals Documentation Labelling 52

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.

Health and Personal Care Stores 52

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).

Health and Personal Care Stores 77

Health and Personal Care Stores Labelling Immunity Immunization 77

LifeProNow

APRIL 19, 2023

The primary endpoint evaluated in this study is progression-free survival, defined as time from randomization to the first documentation of progressive disease or death due to any cause, whichever occurs first. and Europe.” Key secondary endpoints include overall response rate and overall survival.

Adverse Reactions 100

Adverse Reactions Vaccines Immunity Immunization 100

Safe Biologics

MAY 10, 2024

From the post: The HHS Budget in Brief document describes the policy objective simply enough: “ Permit Biosimilar Substitution without Prior FDA Determination of Interchangeability” and clarifies that this means “deem all approved biosimilars to be interchangeable with their respective reference products”.

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Biosimilars Drug Pricing Documentation Labelling 130

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

Pharma in Brief

JANUARY 9, 2022

They have been delayed four times: first to January 1, 2021, then to July 1, 2021, then to January 1, 2022, and most recently to July 1, 2022 (see here and here ). Health Canada also consulted on proposed guidelines for the use of electronic media in prescription drug labelling (see here ).

Documentation 52

Documentation Labelling Vaccines Packaging 52

FDA Law Blog: Biosimilars

JULY 9, 2024

Livornese — The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022, added a requirement that sponsors submit Diversity Action Plans (“DAPs”) for certain clinical studies involving drugs, biological products, or devices (codified at 21 U.S.C. § Would any such failure to meet DAP goals be reflected in labeling?

Drug Development 59

Drug Development Communication Documentation Labelling 59

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. Accessed Dec 7, 2022. Anc Sci Life.

HIV Treatment and Prevention Agents 98

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. Mount Sinai.

Dosage 98

Dosage Documentation Diabetes Labelling 98

Pharmaceutical Technology

JANUARY 6, 2023

Throughout 2022, Novartis was at the opposing ends of legal cases. According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Gilenya is an oral medication for multiple sclerosis. Fighting Entresto generics.

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Documentation Hospitals Dosage Drug Pricing 97

FDA Law Blog: Biosimilars

JANUARY 2, 2025

By Ritte van Laack As we previously reported in 2022, FDA published a proposed rule defining the nutrient content claim healthy. In contrast, the 2022 proposed redefinition focused on food groups recommended by nutrition science and the Dietary Guidelines (DGs), 2020-2025. This category does not include diet sodas, however.

Labelling 52

Labelling Documentation 52

The Thyroid Pharmacist

NOVEMBER 8, 2024

As a side note, I’m excited to share that courtesy of Dr. Kilbane, my son has been eczema-free since 2022. As such, I re-analyzed the data for the “presence” of parasite DNA labels, and the incidence was substantially higher… 274 total parasites were detected! Published 2022 Aug 24. Published 2022 Apr 6. J Lasers Med Sci.

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Immunity Immunization Diabetes Adverse Reactions 70