Conversations in Drug Development Trends

FEBRUARY 21, 2024

Unflinching attention to detail is required to manage AME study participants In AME studies, our top priority is balancing participant comfort and compliance with high-quality data collection. Here are a few of our lessons learned: 1.

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Perficient: Drug Development

JANUARY 24, 2024

Before I begin, I just want to caveat everything with the fact that HIPAA is a complex regulation open to interpretation, and in the end your legal and compliance teams need to be comfortable with how you handle data and the risk associated with those methods. This is because under the covers it is actually using the same instance.

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Perficient: Drug Development

OCTOBER 3, 2024

Support and Compliance: Upgrading ensures continued support from HCL and compliance with industry standards and regulations. Pre-Installation Steps Before upgrading, ensure you have stopped the Java application, disabled all web servers, and ensured that RAD (Rational Application Developer) is not running. Click Next.

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Perficient: Drug Development

SEPTEMBER 26, 2024

Support and Compliance: Upgrading ensures continued support from HCL and compliance with industry standards and regulations. Pre- installation Steps: Before doing an upgrade make sure you have stopped the java application, disable all the web server, ensure that RAD (Rational Application Developer) is not running. Click Next.

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Drug Target Review

DECEMBER 11, 2024

This issue poses a significant hurdle for drug developers, with no universal protocol currently in place to address these complexities. Despite these advancements, analysing biologically derived targets remains a formidable challenge due to interference from endogenous molecules.

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PPD

JULY 9, 2024

Companies developing new drugs and inventing new medical devices face a wide range of challenges. Most industries have in common the need to meet strict timelines while also achieving quality and compliance standards and staying within budget. However, completing this work is only half the challenge.

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Perficient: Drug Development

JANUARY 3, 2024

Even if the hosting and licensing costs are close, the operational costs of managing a true SaaS offering vs. what you need to support PaaS makes it even more compelling. HIPAA Compliance is Coming At Perficient, Healthcare is one of our biggest industry verticals. No upgrades to plan for ever again.

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Conversations in Drug Development Trends

AUGUST 9, 2024

An import license is necessary for any intellectual property or equipment used during the trial. The NMPA and CDE also require compliance with China’s data protection regulations, including the Personal Information Protection Law.

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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. 490.100 titled, “Process Validation Requirements for Drug Products and Active Pharmaceutical Ingredients Subject to Pre-Market Approval.”

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Perficient: Drug Development

NOVEMBER 22, 2023

Compliance and Regulation: Azure AD B2C provides compliance with industry regulations such as GDPR and HIPAA, as well as support for authentication standards like OpenID Connect and OAuth 2.0. This makes it easier for businesses to comply with regulatory requirements and ensure the security of user data.

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The Pharma Data

DECEMBER 30, 2020

For MVR-T3011 intratumoural program, a landmark license program was achieved with Shanghai Pharma along with a validating strategic investment. ” “Our platform and corporate development also made great progress in the second half of 2020.

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Perficient: Drug Development

AUGUST 1, 2023

We tested component functionality, visual design, responsiveness, performance, usability, accessibility, and ADA, HIPAA, and SOC2 compliance. Ultimately, developers need a reliable way to test HTL templates outside of AEM without requiring an AEM license. The sky is the limit.

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Engineering Packaging Compliance Licensing 52

Perficient: Drug Development

FEBRUARY 14, 2024

You’ve got compliance training, processes training, training from corporate leadership, onboarding training for new team members and more. Whether you license content from a health library or write your own, people already know where to go and whom to trust for the educational content. And it’s not you. But that’s OK!

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Engineering International Marketing Compliance 52

Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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Agency IQ

JUNE 2, 2023

The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

JUNE 29, 2023

AgencyIQ’s guidance agenda tracker FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed. The following PDUFA dates were obtained from publicly available sources.

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Perficient: Drug Development

MARCH 29, 2024

Accessibility Compliance As The State of Frontend 2022 study found, respondents pay high attention to accessibility, with 63% predicting this trend will gain more popularity in the coming years. Storybook is released under the MIT license, you can access its source code in the GitHub repository.

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The Pharma Data

NOVEMBER 15, 2020

a publicly traded biopharmaceutical company, from 2012 to December 2019, managing its international, legal, quality, intellectual property and compliance functions, after serving in other executive roles at Acorda starting in 2004. drug development initiative from 2012 to February 2019. Before joining Acorda, Ms.

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Molecule Blog

MARCH 17, 2023

The university then licenses the IP to an existing pharmaceutical company or a biotech startup, which takes on Investigational New Drug (IND) enabling studies. These studies involve more in vivo testing in increasingly larger animals to evaluate safety and efficacy.

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Agency IQ

SEPTEMBER 29, 2023

The following legislative requirements are due within the next two months: Legislation Program Tag Requirement Due Date FDORA, Section 3202 Orphan Drug Program FDA shall publish final guidance related to the draft guidance titled, “Rare Diseases: Common Issues in Drug Development.”

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Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

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Agency IQ

MAY 10, 2024

That EO included some life sciences-specific standards and strategy development, including directing HHS to develop a new strategy on regulating the use of AI or AI-enabled tools in drug development and establish an HHS AI task force, which would focus on safety related to the various health-related uses of AI (e.g.,

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Agency IQ

SEPTEMBER 1, 2023

However, sponsors will still need to ensure the protection of the subjects in their study, including through compliance with 21 CFR parts 50 and 56. The guidance now clarifies that, in addition to NDAs and Biologics License Applications, it also applies to products under Emergency Use Authorization (EUA).

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Agency IQ

DECEMBER 1, 2023

Date Company Drug November 30 Takeda/HUTCHMED Fruquintinib December 8 Vertex / CRISPR Therapeutics Exagamglogene autotemcel December 16 Arcutis Roflumilast December 16 Optinose XHANCE December 16 Merck KEYTRUDA Delayed (Orig. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S.

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Agency IQ

MARCH 1, 2024

FDA March 13 BLA Regulation FDA’s Biologics License Applications and Master Files rule becomes effective FDA March 25 Quality Management Maturity Deadline to participate in the Quality Management Maturity Prototype Assessment Protocol Evaluation Program.

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Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

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Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest. Priority B List.

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Agency IQ

FEBRUARY 2, 2024

What When it might happen Additional details FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

JULY 22, 2024

Facing headwinds, FDA moves ahead on diagnostics policy implementation but faces Congressional, legal, and judicial questions In April 2024, the FDA issued a final rule to update its regulatory approach to certain test products known as Laboratory Developed Tests (LDTs). AgencyIQ provides a status update for regulated industry.

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Agency IQ

MAY 28, 2024

Companies are paying for performance here, and it’s reasonable for them to expect performance” remarked Burgess, “And then we hear other discussions that the FDA wants to vastly expand its authority into licensing laboratory developed tests. If you don’t have the staff to do this, how are you going to have the staff to do that?”

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Perficient: Drug Development

DECEMBER 4, 2024

For organizations using Salesforce, adopting Zero Trust Architecture is critical to securing sensitive data and maintaining regulatory compliance. Ensure Regulatory Compliance : Adhere to frameworks like GDPR, HIPAA, and CCPA by safeguarding sensitive information. Ensuring compliance with financial regulations like PCI DSS and GDPR.

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