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Expanding Generic Drug Access Through International Engagements FEBRUARY 28, 2024 ABOUT THIS WEBINAR FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs. One of the ways OGD supports generic drug regulatory activities is through international engagements. In this webinar, FDA will discuss and provide updates on FDA and EMA’s Parallel Scientific Advice (PSA) Pilot Program for complex generics/hybrid products, address currently available international engagement opportunities, host a panel discussion on topics pertinent to the generic drug industry, and answer questions during live Q&A sessions with FDA and other global regulatory experts. https://lnkd.in/gAYZkGZD

📣 REMINDER - FDA CDER SBIA Virtual Webinar this Friday, May 9th: Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval 📣 #AboutThisWebinar FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs. One of the ways #OGD #supports #generic #drugdevelopment and #regulatory activities is to #provide #constructive #feedback on #proposed #generic #development #plan and #prospective #submission prior to an #AbbreviatedNewDrugApplication (#ANDA) #submission via #meetings. In this #webinar, #FDA will #provide an #overview of the #types of #preANDA #meetings under #GDUFAIII, with #specific #focuses on #changes and #new #features of #presubmission #meetings. FDA will: - Address how the redesigned scope and features of the pre-submission meeting may benefit preparation of ANDA submission and its regulatory assessment post submission - Discuss a hypothetical case to illustrate how to prepare a successful pre-submission meeting request - Host a panel discussion on topics pertinent to the generic drug industry - Answer questions during live Q&A sessions with FDA experts #WhenAndWhere #Date: May 9, 2024 #Time: 1:00 PM - 3:30 PM US EST #Format: Virtual #IntendedAudience - The generic drug industry, consultants, regulatory affairs professionals, or contractors, with an emphasis on those who are involved in generic drug development, plan to submit an ANDA, or are in the process of submitting an ANDA or have submitted an ANDA - Regulatory reviewers for generic drug development and assessments #TopicsCovered - Overview of scope and new features of pre-submission meetings under GDUFA III - Benefits of pre-submission meetings - How and when to utilize pre-submission meetings - Preparation of pre-submission meeting request To read more about the event and find out more about its agenda, please follow the link below.

I am very pleased to announce that on March 26, 2024, I participated in "FDA Drug Topics: Navigating FDA's Drug Information Resources." ⚕️Navigating the FDA's extensive collection of drug information resources, including regulatory updates, drug approvals, safety warnings, and more, was made easier by the insightful discussions throughout this session. 💊 🌟Glad I got the chance to learn more and gain more experience in this exciting industry!💡 FDA FDA - Medical Devices Pharmaceutical Ingredient FDA Regulations FDA Drug Regulations #FDARegulations #ProfessionalDevelopment #PharmaceuticalIndustry #ContinuousLearning

I have successfully completed two days conference on Generic Drugs Forum 2024 Regulatory considerations to enhance generic drug access. The Generic Drugs Forum is an annual, two-day event that offers to hear from FDA subject matter experts from every part of the pre-ANDA program and ANDA assessment program. The goal of the forum is to provide practical regulatory information to aid prospective applicants in submitting complete and high-quality applications to maximize the efficiency and utility of each assessment cycle, with the intent to reduce the number of assessment cycles and facilitate timely access to safe, effective, and high-quality generic medicines. This year’s theme is Regulatory Considerations to Enhance Generic Drug Access, and their agenda will address essential regulatory information on how to engage with the Agency and gain information about ANDA development and ANDA assessment. Topics covered in this event are *Controlled Correspondence *Pre-ANDA Submissions and Meetings *ANDA Submissions, Assessments, and Meetings *Post-Approval Submissions #regulatoryaffairs #USFDA #ANDA #regulatorycompliance

**** MAY 9th WEBINAR*** FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs. One of the ways OGD supports generic drug development and regulatory activities is to provide constructive feedback on proposed generic development plan and prospective submission prior to an Abbreviated New Drug Application (ANDA) submission via meetings. In this webinar, FDA will provide an overview of the types of pre-ANDA meetings under Generic Drug User Fee Amendments (GDUFA) III, with specific focuses on changes and new features of pre-submission meetings. The FDA will: * Address how the redesigned scope and features of the pre-submission meeting may benefit preparation of ANDA submission and its regulatory assessment post submission * Discuss a hypothetical case to illustrate how to prepare a successful pre-submission meeting request * Host a panel discussion on topics pertinent to the generic drug industry *Answer questions during live Q&A sessions with FDA experts

So honored to have been part of a team that represented Vertex Pharmaceuticals at the 2024 Drug Information Association’s Regulatory Submissions Forum in North Bethesda, MD. I got to network with members of the FDA and got updated on the most recent eCTD version 4.0. Our role is to meticulously submit scientific documents and information making it easier for the FDA to review data, approve this new drugs, and monitor drugs after they go on the market. #fdaregulations #DIA #drugdevelopment

Folks...😊!!! **Attended Two days conference on Generic Drugs Forum 2024 Regulatory considerations to enhance generic drug access.** ~ On 10th - 11th April, 2024 + The Generic Drugs Forum is an annual, two-day event that offers to hear from FDA subject matter experts from every part of the pre-ANDA program and ANDA assessment program. The goal of the forum is to provide practical regulatory information to aid prospective applicants in submitting complete and high-quality applications to maximize the efficiency and utility of each assessment cycle, with the intent to reduce the number of assessment cycles and facilitate timely access to safe, effective, and high-quality generic medicines. + This year's theme is Regulatory Considerations to Enhance Generic Drug Access, and their agenda will address essential regulatory information on how to engage with the Agency and gain information about ANDA development and ANDA assessment. Topics covered in this event are :- ~ Controlled Correspondence ~ Pre-ANDA Submissions and Meetings ~ ANDA Submissions, Assessments, and Meetings ~ Post-Approval Submissions #regulatoryaffairs #USFDA #ANDA #regulatorycompliance

On-time submission of Q5 PADER to the US FDA. Decode how Freyr partnered with a US-based generic drug manufacturer to review and prepare PADER submissions to the US FDA. Download the proven case. https://lnkd.in/gU3sxuBD   #PADERSubmissions #USFDA #pharmaceuticals #Q5PADER #RegulatoryAffairs #CaseStudy #ProvenCase #FreyrSolutions

On-time submission of Q5 PADER to the US FDA. Decode how Freyr partnered with a US-based generic drug manufacturer to review and prepare PADER submissions to the US FDA. Download the proven case. https://lnkd.in/gU3sxuBD #PADERSubmissions #USFDA #pharmaceuticals #Q5PADER #RegulatoryAffairs #CaseStudy #ProvenCase

On-time submission of Q5 PADER to the US FDA. Decode how Freyr partnered with a US-based generic drug manufacturer to review and prepare PADER submissions to the US FDA. Download the proven case. https://lnkd.in/gU3sxuBD #PADERSubmissions #USFDA #pharmaceuticals #Q5PADER #RegulatoryAffairs #CaseStudy #ProvenCase