Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

Clinical Trials 40

Clinical Trials Trials Compliance FDA 40

The Pharma Data

AUGUST 17, 2020

DF6002 is a monovalent IL-12 immunoglobulin Fc fusion protein proposed to achieve strong anti-tumor efficacy by establishing an inflammatory tumor microenvironment necessary for productive anti-tumor responses.

Licensing 52

Licensing Licensing Production Clinical Trials 52

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.

Packaging 105

Packaging Licensing Licensing International 105

Drug Discovery World

JULY 16, 2024

That’s as agencies around the world continue to refine and update their requirements, with a bearing on development, marketing approval application and license maintenance processes. Another is in making prompter and more value-added use of regulatory intelligence.

Science 130

Science Production Compliance Marketing 130

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.

Licensing 59

Licensing Licensing Production 59

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FDA draft guidance on addressing misinformation clears White House review A few months ahead of a potential administration transition, the White House has cleared (with changes) a new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products.

FDA 40

FDA Regulations Production Licensing 40

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.

Compliance 52

Compliance Licensing Licensing Regulations 52

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).

FDA 40

FDA Regulations Production Licensing 40

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.

Compliance 52

Compliance Regulations Licensing Licensing 52

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.–(

Licensing 52

Licensing Licensing Pharmaceuticals Disease 52

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.

Licensing 52

Licensing Licensing International 52

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.

Pharmaceuticals 74

Pharmaceuticals Biosimilars Licensing Licensing 74

ASPET

OCTOBER 12, 2023

The Countering Emerging Threats - Rapid Acquisition and Investigation of Drugs for Repurposing (CET RAIDR) program within the JPM Medical is designed to rapidly tackle known, unknown, and emerging threats by utilizing late-stage or licensed therapeutics. Repurposing is one such method.

Therapies 40

Therapies Licensing Licensing FDA Approval 40

Drug Discovery World

JANUARY 31, 2023

But first, there is the urgency of getting the new drug application (NDA) or biologics license application (BLA) filing into the hands of the respective regulatory authorities. Legacy processes often involve passing secure spreadsheets along with PDF documents like Certificate of Analysis.

Production 246

Production Engineering Pharmaceutical Companies Clinical Trials 246

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.

Pharmacy 52

Pharmacy Regulations Licensing Licensing 52

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 (!)

Pharmaceuticals 75

Pharmaceuticals Biosimilars Licensing Licensing 75

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.

Licensing 52

Licensing Licensing Marketing Research 52

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.,

Nurses 52

Nurses Licensing Licensing Research 52

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.

Science 40

Science FDA Production Regulations 40

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

Licensing 52

Licensing Licensing 52

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.

Pharmacy 52

Pharmacy Drugs Regulations Compliance 52

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.

Pharmaceuticals 40

Pharmaceuticals Specialty Pharmacies Pharmacy Biosimilars 40

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.

Trials 80

Trials Clinical Trials Regulations FDA 80

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.

Biosimilars 40

Biosimilars FDA Production Licensing 40

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 (..)

Therapies 40

Therapies Licensing Licensing FDA 40

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.

Licensing 52

Licensing Licensing Packaging Laboratories 52

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.

Pharmacy 98

Pharmacy Specialty Pharmacies Licensing Licensing 98

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?

FDA 52

FDA Clinical Trials Licensing Licensing 52

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.

Regulations 40

Regulations Production Science Vaccine 40

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.

Compliance 52

Compliance Licensing Licensing Production 52

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 (..)

Licensing 52

Licensing Licensing 52

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.

Compliance 118

Compliance Marketing Licensing Licensing 118

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.

Research 52

Research Licensing Licensing Science 52

Agency IQ

AUGUST 16, 2024

The June 2023 guidance recommends that studies involve two monitors (one with graduate-level professional training and clinical experience in psychotherapy, licensed to practice independently) to observe study participants during treatment sessions. The plan would also include an implementation system and timeline for assessment submission.

FDA 40

FDA Trials Regulations Therapies 40

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.

FDA 40

FDA Science Regulations Production 40

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.

FDA 52

FDA Licensing Licensing Therapies 52

Agency IQ

AUGUST 2, 2024

An earlier iteration of that report detailed how the agency wanted to change some of its practices surrounding the publication of guidance documents. However, the draft document was somewhat FDA-focused, and industry asked the agency to incorporate other ideas into the final version. This is what OIRA is currently reviewing.

FDA 40

FDA Science Regulations Biosimilars 40