FDA Law Blog: Biosimilars

JULY 29, 2024

Last week, FDA issued draft guidance to address the potential complications that arise when sponsors seek to modify products, production processes, or quality controls for approved biologics license application (BLA) biosimilar and interchangeable products.

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Perficient: Drug Development

NOVEMBER 10, 2023

Depending on the size of the team and anticipated activity within a program, additional RDEs can also be provisioned, however, this may come at an additional licensing cost from Adobe. For more options and details on resetting the RDE for your program, review Adobe’s documentation on Experience League on this page.

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Perficient: Drug Development

JUNE 1, 2024

Document the specific changes made to the permission set and assign it to a test user to check if the modifications are reflected correctly. Test with different license types : If the permission set is assigned to users with different license types, test it with each license type to ensure that the permissions work as expected.

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Perficient: Drug Development

FEBRUARY 15, 2024

Issues and Findings Management: Document issues and gaps identified during risk assessments and control testing, crucial for compliance. DFS500 Compliance Requirements Institutions falling under the purview of the DFS500 amendments encompass a diverse spectrum, all mandated to adhere to these regulations.

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The Pharma Data

DECEMBER 16, 2020

NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”) today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar. VICTORIA, British Columbia & ROCKVILLE, Md.–(

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Perficient: Drug Development

FEBRUARY 15, 2024

Issues and Findings Management: Document issues and gaps identified during risk assessments and control testing, crucial for compliance. Compliance Requirements Institutions falling under the purview of the NYSDFS Part 500 amendments encompass a diverse spectrum, all mandated to adhere to these regulations.

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Agency IQ

JUNE 28, 2024

FDA draft guidance on addressing misinformation clears White House review A few months ahead of a potential administration transition, the White House has cleared (with changes) a new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products.

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Agency IQ

MAY 28, 2024

New FDA guidance on addressing misinformation under White House review A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of Information and Regulatory Affairs (OIRA).

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Perficient: Drug Development

JULY 17, 2024

This process is well documented. I read through this documentation multiple times and did not really understand the process until I needed to implement it for myself. In order to identify a guest, we must send an “IDENTITY” event. If you have been confused by identity in CDP, read on! CDP allows the same behavior digitally.

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Molecule Blog

AUGUST 6, 2021

Therefore, it is common to use license agreements to structure the terms surrounding the IP. Before and after the transaction, access to the IP and relating license agreements need to be managed by the parties. c) Data-storage Layer The second category of data to be handled is the IP and license agreement themselves.

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FDA Law Blog: Biosimilars

AUGUST 9, 2023

Two licensed pharmacists must directly communicate the transfer. As with other required controlled substance records, electronic records documenting EPCS transfers must be maintained for two years from the transfer date by both the transferring and receiving pharmacies. cannot be altered during the transmission.

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The Premier Consulting Blog

NOVEMBER 20, 2024

This process can be initiated during the review period of the biologics license application (BLA) or new drug application (NDA) prior to approval. Note that pre-approval inspections for biologics are referred to as pre-licensing inspections (PLI).

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Drug Channels

OCTOBER 11, 2022

Licenses for our DCI reports are regularly purchased by nearly every company involved in the drug channel: pharmaceutical manufacturers, wholesalers, pharmacists, pharmacy owners, hospitals, buyers, benefit managers, managed care executives, policy analysts, investors, lawyers, consultants, and more.

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The Pharma Data

DECEMBER 21, 2020

from the University of New Hampshire in Durham, and colleagues used data from the Current Population Survey (2010 to 2019) to document the rate of nursing and long-term care workers who hold second jobs. percent of licensed practical nurses and registered nurses held second jobs. Baughman, Ph.D.,

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Agency IQ

MAY 31, 2024

Unpacking FDA’s long-awaited platform technology designation program and guidance Months overdue, the FDA’s Platform Technologies Designation guidance document has just been published by the agency. AgencyIQ breaks down what the designation means for sponsors and its limits for product sponsors. which would never be acceptable.

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Agency IQ

JULY 26, 2024

The Q&A then summarizes some of the key aspects of that document, including comparability assessment contents and the use of reference materials. Supplements of this type “generally should include the following CMC-related information: (1) adequate comparability data between a licensed biosimilar or interchangeable biosimilar (i.e.,

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Drug Channels

OCTOBER 5, 2021

Licenses for our DCI reports are regularly purchased by nearly every company involved in the drug channel: pharmaceutical manufacturers, wholesalers, pharmacists, pharmacy owners, hospitals, buyers, benefit managers, managed care executives, policy analysts, investors, lawyers, consultants, and more. There are an astonishing 537 (!)

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Agency IQ

APRIL 26, 2024

The November 2020 document, entitled Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act , clarified that, for the most part, labeling for interchangeable products should follow the same guidance proposed for other biosimilars. Read AgencyIQ’s analysis of this guidance here.]

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Drug Channels

OCTOBER 10, 2023

Licenses for our DCI reports are regularly purchased by nearly every entity involved in the drug channel: pharmaceutical manufacturers, wholesalers, pharmacists, pharmacy owners, hospitals, buyers, benefit managers, managed care executives, policy analysts, investors, consultants, and more. The exhibits appear in all license versions.

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The Pharma Data

DECEMBER 21, 2020

Johnson & Johnson (J&J) and Legend Biotech said they have begun submitting documents on a rolling basis to the FDA for a Biologics License Application for their investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T (CAR-T) therapy, ciltacabtagene autoleucel (cilta-cel), meant for adults suffering from relapsed (..)

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Perficient: Drug Development

JANUARY 18, 2024

To convert and compress the Sitecore license to base 64 string, run the script present in “ConvertTo-CompressedBase64String” method present in the upgrade guide. Review the readme and KCD Documentation file. Execute the scripts as mentioned in the documentation. DATABASE_UPGRADE_TO_VERSION=10.3.1

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Agency IQ

AUGUST 25, 2023

Read AgencyIQ’s full analysis of the BsUFA Commitment Letter here.] Regulatory Context: Labeling for Biosimilar Products In 2018, the FDA released a guidance document entitled Labeling for Biosimilar Products. The exact text can be found in the guidance document and in an approved biosimilar product label.

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Agency IQ

MAY 10, 2024

What life sciences companies need to know about NIST’s new AI guidance The National Institute of Standards and Technology (NIST) last week released four new documents on artificial intelligence, mostly focusing on generative AI (GAI). NIST has released four new initial draft documents on AI Up first: Meet NIST’s work so far.

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Molecule Blog

JANUARY 18, 2023

The current NFT owner can legally prove that they’re holding the IP rights by downloading and verifying the attached legal documents on their own machine. This capturing step is necessary because the legal documents attached to the final IP-NFT are referring to the NFT’s token id that only becomes available after the mint has occurred.

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The Premier Consulting Blog

MAY 14, 2023

Instead, if the “Yes” box is ticked to include CRO information, a “Continuation Page for #16” button appears, and the continuation page appends to the end of the document, where the transfer information can be added. A: You may receive an “unsupported document” error when using DocuSign to sign the form. How can I resolve this?

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FDA Law Blog: Biosimilars

JUNE 27, 2024

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. It also states that “[t]he pharmacist shall record any related information indicated by a licensed health care practitioner.” Id.

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Perficient: Drug Development

NOVEMBER 7, 2023

Here we will outline several distinctions between two prominent tools: Acunetix and Burp Suite: Aspect Acunetix Burp Suite Scanner Vendor Acunetix by Invicti Security Burp Suite by PortSwigger User Interface User-friendly, guided scans Comprehensive, flexible interface Scanning Depth Deep scanning capabilities Deep and extensive scanning Automated (..)

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Agency IQ

FEBRUARY 15, 2024

Modeled after a similar pathway for pharmaceuticals – the Innovative Licensing Access Pathway (ILAP) – the new pilot program intends to ensure end-to-end assistance for developers of innovative devices addressing unmet medical needs. and abroad. To contact the author of this item, please email Corey Jaseph.

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Drug Channels

MARCH 15, 2022

Licenses for our DCI reports are regularly purchased by nearly every company involved in the drug channel: pharmaceutical manufacturers, wholesalers, pharmacists, pharmacy owners, hospitals, buyers, benefit managers, managed care executives, policy analysts, investors, consultants, and more.

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Perficient: Drug Development

JANUARY 19, 2024

This distribution utilizes licensed API keys, streamlining the process for customers to conveniently retrieve and access these containers in their local registries or incorporate them seamlessly into their CI/CD pipelines.

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Perficient: Drug Development

MARCH 29, 2024

Each of them is developed, tested, and documented separately from the others, which simplifies the process of developing and maintaining the application as a whole. It provides the ability to run automated tests, analyze various interface states, work with mock data, create documentation, and even conduct code reviews.

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Conversations in Drug Development Trends

AUGUST 9, 2024

Managing this complexity highlights the importance of global communication plans and constant communication with global regulators and keeping all required documentation up to date. An import license is necessary for any intellectual property or equipment used during the trial.

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Molecule Blog

JANUARY 9, 2023

IP-NFTs upgrade our legacy intellectual system by unifying IP (patents, legal), underlying data (through decentralized storage and access control), and economics (royalties, license fees, sales) into one programmable, transactable, digital unit. ‍ Licensing fees and revenue generated flow back to the smart contract (eg.

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The Pharma Data

JANUARY 3, 2021

The FDA accepted the Biologics License Application for ide-cel, an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, under priority review in September. The CVR hinged on U.S. regulatory approval of three drugs, Zeposia, ide-cel and liso-cel. 16 PDUFA date.

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The Pharma Data

JANUARY 10, 2021

Download the slideshow of meetings on the Company website, in the Documentation section dedicated to investors: www.valbiotis.com/en/documents/. Its products are intended to be licensed to players in the health sector. Its products are intended to be licensed to players in the health sector.

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Agency IQ

JULY 8, 2024

In early June, we’re expecting to see what the FDA will allow life sciences companies to do in this fight as it releases a new draft guidance document. In early June, we’re expecting to see what the FDA will allow life sciences companies to do in this fight as it releases a new draft guidance document. and the E.C.

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Advarra

JULY 19, 2022

A: For all vendors, having documented qualifications prior to use is important. For GMP vendors, documented reviews of records such as analytical testing and batch records, is also important. The auditor prepares by reviewing relevant information, such as contracts, as well as select QMS documents and records.

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