FDA Law Blog: Biosimilars

AUGUST 11, 2024

The approved labeling for AUVI-Q includes warnings and precautions regarding emergency treatment, injection-related complications, serious infections at the injection site, allergic reactions associated with sulfite, and disease interactions. The Mirati letter deals with much more nuanced issues than the letter to kaleo.

Labelling 59

Labelling Communication 59

FDA Law Blog: Biosimilars

APRIL 25, 2023

The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers. It applies whether the software is the entire device (i.e., Software in a Medical Device, or SiMD). Loose Ends IDEs.

Documentation 105

Documentation Labelling Communication 105

pharmaphorum

FEBRUARY 26, 2021

Robert Wood’s granddaughter, Mary Lea, was the first baby to be used on the baby powder label. But like many of its big pharma peers, it faces increased pressure on some of its biggest brands, as expiring patents pave the way for generic competition while biosimilars undercut sales of biologics. Litigation & controversy.

Vaccines 126

Vaccines Biosimilars Labelling Communication 126

FDA Law Blog: Biosimilars

JULY 10, 2023

FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. For labeling documents and the 510(k) summary, FDA often requests both clean and redlined versions.

Documentation 75

Documentation Packaging Communication Labelling 75

FDA Law Blog: Biosimilars

AUGUST 16, 2023

Prior to the CytoDyn letter in 2022, OPDP issued a Warning Letter in 2021 to CooperSurgical for a DTC video entitled “Paragard: Family Planning During the Pandemic” which failed to communicate ANY risk information. This seems to suggest that FDA expects this type of outcome claim to be included in labeling.

Labelling 52

Labelling Controlled Substances Communication 52

FDA Law Blog: Biosimilars

JUNE 27, 2023

We have seen companies submit screenshots of social media sites making misleading promotional claims, pictures of violative product labeling, and evidence of damaged or uncalibrated manufacturing equipment. There are drawbacks to the current communication channels: 1.) We hope the status is more than just an “Under Review” label.

Documentation 59

Documentation Labelling Communication 59

FDA Law Blog: Biosimilars

OCTOBER 10, 2023

Labeling and Implant ID Card Lastly, it is critical that patients are provided with implant information as it pertains to their devices. separate patient labeling). Manufacturers should create user-friendly instructions for use that facilitate patient understanding of potential risks over the expected lifespan of the implant.

Documentation 45

Documentation Labelling Communication 45

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

The guidance describes elements that would be required of VCS bodies for recognition of standards they adopt: openness (with meaningful opportunities to participate), balance (broad range of stakeholders), due process, an appeals process, and consensus.

Packaging 59

Packaging Documentation Labelling Communication 59

FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

Corrections and Removals Under 21 CFR Part 806, manufacturers generally need to communicate corrections and removals (i.e., FDA plans to hold its next webinar on September 24, 2024, which will cover the labeling requirements that go into effect in Stage 2. It should be noted that 21 CFR 803.18(b)(1)(ii)

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Labelling Communication 64

Putting Patients First Blog

JANUARY 27, 2025

3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. Comprehensive Transparency: AI applications should be fully disclosed, explainable, and accessible to patients and providers in layperson terms.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Biosimilars Communication Department of Veterans Affairs 40

FDA Law Blog: Biosimilars

JANUARY 22, 2025

Wasserstein & Dara Katcher Levy Who among us, upon reading FDAs draft guidance on the distribution of off label information and their coining of the acronym SIUU (standing for Scientific Information on Unapproved Uses ) did not automatically think of Phil Collins classic song Sussudio ? By Jeffrey N. Other than anyone under 50, that is.

Labelling 59

Labelling Communication 59

RX Note

DECEMBER 25, 2024

Off label use information can be found here too. However, with the proliferation of biosimilars and liposomal or pegylated forms, health care professionals are now encouraged to communicate using product name for certain circumstances (e.g. Few years back, doctors are urged to prescribe drugs by active ingredients.

Biosimilars 52

Biosimilars Community Pharmacies Labelling Communication 52

FDA Law Blog: Biosimilars

NOVEMBER 29, 2023

Considerations include transparency regarding the data used to develop the change, comprehensive testing of the change, characterizing the performance of the device before and after the change, and plans in place for ongoing monitoring of device performance and communication of any unexpected changes in performance.

Labelling 115

Labelling Communication 115

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. Human Touch - Why Artificial Intelligence cannot replace us still? Theory in Practice - Life is not ideal but a struggle Life - Why?

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

FDA Law Blog: Biosimilars

JULY 9, 2024

If FDA determines that a waiver will be issued, it may consider public communications about the decision. Since it is only the submission of the plan that is required by law, how, if at all, will FDA communicate that a plan does not meet the requirements for submission? Some unanswered questions remain.

Drug Development 59

Drug Development Communication Documentation Labelling 59

PharmaShots

APRIL 3, 2023

It now offers DPN patients relief from chronic pain through low doses of stimulation & the battery lasts up to 10 years at low-dose settings The system also pairs with Abbott’s NeuroSphere Virtual Clinic, a connected care app for people to communicate with a physician and receive remote treatment adjustments. The authorization incl.

Biosimilars 40

Biosimilars Diabetes Compounding Hospitals 40

FDA Law Blog: Biosimilars

FEBRUARY 13, 2025

The manufacturer should, in addition to stating whether the modification will be implemented manually or automatically, include details such as: End user actions needed, if any to implement the change, Timing of implementation, Extent of implementation in the install base, and Include references to expected labeling changes.

Documentation 71

Documentation Labelling Method Validation Communication 71

FDA Law Blog: Biosimilars

JANUARY 12, 2025

It will be important for FDA to communicate to sponsors its views on whether a product would address an unmet medical need on mechanistic grounds to help ensure greater certainty for investment in the development of therapies for these serious conditions. in Duchenne Muscular Dystrophy).

Drug Development 64

Drug Development Communication Labelling 64

Pharmaceutical Technology

DECEMBER 4, 2022

Starting in January, multiple biosimilars of AbbVie’s blockbuster drug Humira are set to flood the US pharmaceutical market. The arrival of Humira biosimilars is expected to provide cost-effective alternatives to the anti-tumor necrosis factor (TNF) biologic, but their eventual position on the market remains to be seen.

Biosimilars 104

Biosimilars Labelling Communication Hospitals 104

FDA Law Blog: Biosimilars

FEBRUARY 5, 2025

Labeling Labeling Section VII Risk Assessment Risk Management File of Software Documentation Section VIII Data Management Data for development: Software Description of Software Documentation Data for testing: Performance Testing Section IX Model Description and Development Software Description Section X.A

Documentation 95

Documentation Labelling Communication 95

FDA Law Blog: Biosimilars

FEBRUARY 20, 2025

In fact, FDA has three guidances on its A list planned for this fiscal year that are specifically related to the LDT Rule or IVD (which FDA says includes LDTs) labeling (see here ). This inability to consult external experts could make communicating with FDA on important topics of safety and effectiveness even more challenging.

Labelling 102

Labelling Communication 102