Phil Garner’s Post

The FDA has released a report on the use of RWE in regulatory submissions, providing transparency and insights into how RWD is utilized to support the safety and effectiveness of drugs and biological products. This ongoing reporting aims to enhance understanding and confidence in the integration of RWE in regulatory decision-making processes. Read below for the full report, and thank you Phil Garner for sharing this important report that supports the use of RWD to support RWE!

📢 FDA Releases Updated Draft Guidance for Formal Meetings on PDUFA Products In a pivotal move, the U.S. Food and Drug Administration (FDA) has unveiled the revised draft guidance titled "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products." This updated guidance supersedes the previous version issued in December 2017. The newly released draft guidance offers comprehensive recommendations to industry stakeholders concerning formal engagements between the FDA and sponsors or applicants involved in the development and evaluation of drug or biological drug products. It intricately delineates various meeting types, their respective formats, and associated timelines for requesting these crucial interactions. Furthermore, it emphasizes the importance of a thorough meeting request and background package, elucidating essential information vital for a productive discussion aimed at enhancing product development. Notably, the draft guidance includes illustrative examples, aiming to assist stakeholders in choosing and requesting the most suitable meeting type for specific scenarios. The FDA invites and encourages valuable comments and feedback on this draft guidance, to be submitted as per the outlined procedures in the notice of availability, soon to be published in the Federal Register. Stay tuned for further updates on this significant development, shaping the landscape of pharmaceutical product development and regulatory engagement. 🌟 #FDA #DrugDevelopment #PDUFA #HealthcareRegulation

The ABC of ANDAs (abbreviated new drug applications) and more on revised FDA guidance “To improve the quality of applications and ensure improved consistency, the FDA has developed guidance3 to assist applicants in preparing and submitting amendments to tentatively approved ANDAs or in seeking final approval (the ‘earliest lawful ANDA approval date’). The guidance outlines a series of recommendations relating to the timing and content of amendments so the chances of success by the applicant are improved.” Great compilation of Revised FDA guidance - *Requirements *Bioequivolance *Legal assessment *Submitting amendments *Ensuring Sufficient And Complete Responses *Post - change Updates The guidance has been revised in response to language included in the Generic Drug User Fee Amendments of 20224 (following previous revisions in 2012 and 2017). The latest amendment sets goals for the FDA for the fiscal years 2023 to 2027, including goals and targets for the FDA's generic drug assessment program. By Dr Tim Sandle, Ph.D., CBiol, FIScT , He is a pharmaceutical professional with wide experience in microbiology and quality assurance and author of more than 30 books relating to pharmaceuticals, healthcare, and life sciences, as well as over 170 peer-reviewed papers and some 500 technical articles. Original credits : https://lnkd.in/gaUwu_Fe

📢 FDA Releases Updated Draft Guidance for Formal Meetings on PDUFA Products In a pivotal move, the U.S. Food and Drug Administration (FDA) has unveiled the revised draft guidance titled "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products." This updated guidance supersedes the previous version issued in December 2017. The newly released draft guidance offers comprehensive recommendations to industry stakeholders concerning formal engagements between the FDA and sponsors or applicants involved in the development and evaluation of drug or biological drug products. It intricately delineates various meeting types, their respective formats, and associated timelines for requesting these crucial interactions. Furthermore, it emphasizes the importance of a thorough meeting request and background package, elucidating essential information vital for a productive discussion aimed at enhancing product development. Notably, the draft guidance includes illustrative examples, aiming to assist stakeholders in choosing and requesting the most suitable meeting type for specific scenarios. The FDA invites and encourages valuable comments and feedback on this draft guidance, to be submitted as per the outlined procedures in the notice of availability, soon to be published in the Federal Register. Stay tuned for further updates on this significant development, shaping the landscape of pharmaceutical product development and regulatory engagement. 🌟 #FDA #DrugDevelopment #PDUFA #HealthcareRegulation

Quiz Time What does "FDA" stand for in the context of drug approval? Drop the answers in the comment section below! a) Food and Drug Administration b) Federal Drug Agency c) Pharmaceutical Development Authority d) Drug Approval Foundation #FDA #Quiz #medicine #medical #clinicalresearch #pharmaceuticals #pharma #clinical #clinicaltrials #JSTL #Jeevanscientific #Jeevanscientifictechnologylimited

Notably, the draft guidance includes illustrative examples, aiming to assist stakeholders in choosing and requesting the most suitable meeting type for specific scenarios. The FDA invites and encourages valuable comments and feedback on this draft guidance, to be submitted as per the outlined procedures in the notice of availability, soon to be published in the Federal Register. This significant development will shape the landscape of pharmaceutical product development and regulatory engagement. Stay tuned for further updates on this crucial matter. 🌟 #FDA #DrugDevelopment #PDUFA #HealthcareRegulation

What is the IMP in clinical trials? What is considered IMP in a clinical trial and what is not? 💡 We speak constantly about IP or IMP. What is it? The Investigational Product (IP) or Investigational Medicinal Product (IMP) is a pharmaceutical product that is being studies in a clinical trial setting. 🧑🔬 The word “investigational” already tells us that this product is not approved by the regulatory authorities to be on the market and prescribed for the general use. It is still in research, being “investigated”. 😜🔬 So, what is an IMP? Is it any product? What types of products? Here are the categories of what is considered an IMP: 👉 Preventive products: vaccines 👉 Therapeutic products: drug or biologic 👉 Device product 👉 Diagnostic product 👉 Palliative product #clinicalresearchassociate #clinicaltrials #clinicalresearch #investigational product

#Bioequivalence (BE) study Bioequivalence is defined as “the absence of significant difference in the rate and extent of #bioavailability between two pharmaceutical equivalents or pharmaceutical alternatives under similar conditions”. The generic version must deliver the same amount of #activeingredients into a patient's bloodstream in the same amount of time as the innovator drug. The concept of bioequivalence testing became more prominent in the United States with the passage of the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act. This legislation created a framework for the approval of generic drugs and established the need for generic drug manufacturers to demonstrate bioequivalence to the reference (brand-name) drug. ♦️"Hatch-Waxman Act-1984" The Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act” is a United States federal law which established the modern system of #GENERICDRUGS. The informal name comes from the Act's two sponsors, Henry Waxman of California, and Senator Orrin Hatch of Utah. The main objective of this act is to provide less costly generic drugs by permitting #FDA to approve applications to market generic versions of brand name drugs without conducting costly and duplicative clinical trials. This act established bioequivalence as the basis for approving generic copies of drug products. As per this act a Generic Drug (#ANDA) does not require to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). #bioequivalence #pharmaceuticals #genericdrugs #researchanddevelopment