FDA Law Blog: Biosimilars

JUNE 10, 2024

It is critical that this guidance be reviewed in tandem with the guidance set forth in FDA’s Investigations Operations Manual (IOM) and the Regulatory Procedures Manual (RPM) , both of which provide more detail about how FDA investigators conduct investigations and make decisions about a firm’s regulatory compliance.

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Perficient: Drug Development

JUNE 19, 2024

Our risk and regulatory compliance experts, Carl Aridas and Chandni Patel, have just returned from XLoD 2024 in New York. Conquer Compliance The insights that Carl and Chandni gathered at XLoD highlight the ongoing evolution within the industry.

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Perficient: Drug Development

FEBRUARY 12, 2025

This transformation will require a delicate balance between innovation and compliance, ensuring that advancements in AI contribute to a secure and efficient payments landscape. These changes require significant adjustments in risk management, compliance frameworks, and operational protocols.

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Perficient: Drug Development

SEPTEMBER 6, 2024

What Makes Salesforce a Leader in B2B E-Commerce: Key Takeaways from the Forrester Wave Q2 2024 Michael Affronti , Executive VP & GM of Commerce Cloud at Salesforce, recently expressed his excitement on LinkedIn about Salesforce being named a Leader in the Forrester Wave: Commerce Solutions for B2B, Q2 2024 report.

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Broad Institute

JANUARY 24, 2024

Terra is now generally available on Microsoft Azure By Allessandra DiCorato January 24, 2024 Breadcrumb Home Terra is now generally available on Microsoft Azure Terra on Microsoft Azure expands support for enterprises and data scientists across the globe. Compliance agreements: Terra can now sign HIPAA Business Associate Agreements for U.S.

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Fierce BioTech

OCTOBER 26, 2023

Are you struggling to keep track of privacy and compliance regulations across multiple countries and grant types? Join a team of medical grants experts to learn about common grantmaking challenges and tools for tackling them in 2024. Listing Image Bonterra-LogoListing-12072023.png On Demand Start Date Thu, 12/07/2023 - 14:00

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FDA Law Blog: Biosimilars

DECEMBER 7, 2023

Gonzalez — The annual Enforcement, Litigation, and Compliance Conference put on by the Food and Drug Law Institute (“FDLI”) took place in Washington this week. As that may develop, the 2024 edition of this conference will be worth coming back for. By Steven J.

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Perficient: Drug Development

MAY 1, 2024

As of mid-February 2024, the Spring ‘24 release was generally available across all instances of Health Cloud bringing with it a host of improvements and added functionality for healthcare organizations. Additionally, optimized time-to-therapy enhancements and transportation logistic modeling enhance operational efficiency and compliance.

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Advarra

AUGUST 8, 2024

We also summarize the key information pharmaceutical companies and contract research organizations (CROs) need to know to prepare for compliance. While some of the AI Act’s compliance dates are set for August 2024, the full Act will be enforced in March 2026.

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Perficient: Drug Development

SEPTEMBER 9, 2024

Here are the key takeaways and insights you should know coming into Dreamforce 2024: The Agentic AI Approach: Automation at Scale The crux of Agentforce lies in its ability to deploy multiple autonomous AI agents within an organization. Data Cloud: Fueling AI with High-Quality Data In any AI endeavor, data is the key to success.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

(HP&M) proudly announces that Director Anne Walsh will be a featured panelist at the highly anticipated 2024 Women’s White Collar Defense Association (WWCDA®) Leadership Retreat and Annual Attorney Meeting. The event is set to take place from March 4-6, 2024, in San Francisco, California.

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

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Fierce BioTech

FEBRUARY 13, 2024

Streamlining Compliance: Outsourcing combined services and technology in pharmacovigilance and regulatory affairs Biotech and pharma companies are already tapping into the benefits of outsourcing. dfarris Tue, 02/13/2024 - 12:20 Biotech and pharma companies are already tapping into the benefits of outsourcing.

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Alta Sciences

JULY 25, 2024

Top 10 Life Science Resources for Summer 2024 pmjackson Thu, 07/25/2024 - 14:44 There’s a lot of life science content out there, which is why we’ve curated a selection of our expert insights, tips, case studies, and scientific and regulatory information for your convenience. Catch up on what you might have missed below!

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Perficient: Drug Development

JANUARY 3, 2024

As we enter 2024, most of the conversations we have are focused on XM Cloud. HIPAA Compliance is Coming At Perficient, Healthcare is one of our biggest industry verticals. At the same time, front end hosting partners Vercel and Netlify have both indicated HIPAA compliance and BAA agreements should be supported early in 2024.

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico. Two Hyman, Phelps & McNamara, P.C.

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Drug Channels

OCTOBER 7, 2024

How can I ensure compliance with ERISA requirements? Drug Channels readers will save 10% off when they use code 24DRCH10 and register prior to November 8, 2024.* © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. What is the best way to design and optimize benefits for covering GLP-1s?

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FDA Law Blog: Biosimilars

SEPTEMBER 17, 2024

By Sarah Wicks & Dara Katcher Levy — FDA’s Office of Prescription Drug Promotion (OPDP) has issued its fourth Untitled Letter of 2024 – this one to AbbVie, Inc. AbbVie), for a direct-to-consumer (DTC) TV advertisement for its drug UBRELVY (ubrogepant) that features tennis star, social media influencer and entrepreneur Serena Williams.

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Advarra

MARCH 19, 2024

The Food and Drug Administration’s (FDA’s) February 2024 draft guidance Use of Data Monitoring Committees in Clinical Trials signals a significant shift in approach. Open for public comment until April 15, 2024, this draft seeks to modernize and clarify the agency’s expectations for DMC oversight.

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Fierce BioTech

SEPTEMBER 23, 2024

Apply the Power of Automation to GxP Systems This timely whitepaper explores the capabilities life sciences companies should expect from an end-to-end automation solution to streamline compliance, increase reliability, and reduce costs. Download now. Download now.

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Fierce BioTech

JULY 15, 2024

Nitrosamines in Focus: Regulatory Requirements and Best Practices dwunderlin Mon, 07/15/2024 - 11:10 Thu, 09/12/2024 - 10:00 Resource Type Webinar Chris Williams Chad Bastian Duration 60 Minutes Nitrosamines, potent carcinogens, have prompted stringent regulations for their detection and control in various products.

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Drug Channels

OCTOBER 21, 2024

Informa Connect’s Trade and Channel Strategies December 10-12, 2024 at the W Hotel in Philadelphia, PA Drug Channels readers save 10% with code 24DC10 * Pharmacy and distribution models are growing increasingly complex. © 2006-2024 HMP Omnimedia, LLC d/b/a Drug Channels Institute , an HMP Global Company. What is the secret to success?

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Perficient: Drug Development

FEBRUARY 15, 2024

The NYSDFS Part 500 amendments signal a crucial shift in the financial services regulatory landscape and underscore the importance of robust governance, risk management, and compliance frameworks. Impacted institutions are subject to significant fines relative to the level of non-compliance identified by the regulators.

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Agency IQ

NOVEMBER 10, 2023

The FDA announced it intends to delay enforcement of cosmetic facility registration and cosmetic product listing requirements to July 1, 2024, from the current deadline of December 29, 2023 as required by Modernization of Cosmetics Regulation Act or MoCRA.

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Alta Sciences

NOVEMBER 4, 2024

Case Study: How to Ensure Safety While Manufacturing Highly Potent APIs aasimakopoulos Mon, 11/04/2024 - 17:37 Highly potent active pharmaceutical ingredients (API) require careful attention to safety and handling during formulation and manufacturing.

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Perficient: Drug Development

FEBRUARY 15, 2024

These DFS500 amendments signal a crucial shift in the regulatory landscape, emphasizing the imperative for robust governance, risk management, and compliance frameworks across the financial industry. Impacted institutions are subject to significant fines relative to the level of non-compliance identified by the regulators.

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Alta Sciences

FEBRUARY 19, 2025

Regulatory Considerations for Oligonucleotide Drug Development and Safety In 2024, the U.S. Our experts stay up to date on all new and evolving regulations to guarantee regulatory compliance in your studies. An oligonucleotide is a short strand of nucleotides, the building blocks of DNA or RNA, used in genetic research and therapy.

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DS in Pharmatics

JUNE 12, 2024

Date: June 12, 2024 Location: San Diego, CA ProductLife Group (PLG), a leading provider of product development and compliance services in the pharmaceutical and biotechnological sectors, is excited to announce a comprehensive solution aimed at transforming the landscape of drug development, underscoring PLG's commitment to advancing healthcare through (..)

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Fierce BioTech

APRIL 11, 2024

Benefits: Gain insights into GMP compliance, understand critical considerations for storage optimization, and learn about Alcami's unique capabilities. png Listing Introduction Discover the critical factors driving GMP compliance with five crucial considerations for pharmaceutical storage. On Demand Start Date Wed, 05/22/2024 - 12:00

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Drug Channels

SEPTEMBER 16, 2024

Informa Connect's Patient Support Services Congress November 20-21, 2024 | Hilton Penn’s Landing, Philadelphia, PA Drug Channels readers save 10%* with code 24DC10. Tailored Tracked Content for a Customizable Experience Compliance and Legal Innovation and Operations And more! All rights reserved.

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Agency IQ

MAY 3, 2024

What we expect European regulators to do in May 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more. and national regulators.

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Perficient: Drug Development

DECEMBER 27, 2023

YOU MAY ENJOY: Regulatory Reporting in Financial Services Modernizing CRA Regulations Managing compliance risk frameworks in alignment with existing risk profiles is crucial as customer needs evolve. The effective date of the new rule is April 1, 2024, with key provisions taking effect on January 1, 2026, and January 1, 2027. Banks

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Fierce BioTech

MAY 7, 2024

Trust Transformed: Pharma Marketing in the Post-Cookie Era dwunderlin Tue, 05/07/2024 - 13:29 Tue, 06/11/2024 - 14:00 Resource Type Webinar David Minkin Clifton Covey Sonia V Gupta Duration 60 Minutes In the backdrop of digital advertising for pharmaceuticals we are undergoing a radical transformation as privacy becomes a paramount concern.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

This essential event for regulatory professionals in the biopharmaceutical and medical device industries will take place March 12-13, 2024, in Arlington, VA. Attendees can expect to gain practical strategies for compliance and enforcement, drawn from Ms. Before joining HP&M, Ms.

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thought leadership

SEPTEMBER 25, 2023

With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization?

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PPD

OCTOBER 31, 2024

Key factors contributing to this trend include the enrollment of hard-to-find patient populations and compliance with complex regulatory requirements. 2024 trends with momentum Personalized/precision medicine: Tailoring treatments to individual genetic profiles and specific patient characteristics is becoming increasingly important.

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Perficient: Drug Development

NOVEMBER 21, 2024

The first compliance deadline of April 1, 2026, impacts the largest organizations. The compliance deadline, however, depends on the firm’s total receipts from calendar years 2023 and 2024. The compliance deadline, however, depends on the firm’s total receipts from calendar years 2023 and 2024.

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