Source: Pharmaceutical Technology
The FDA released a draft guidance, answering questions on charging for investigational drugs under an IND. Credit: Vi_L via Getty Images
The US Food and Drug Administration (FDA) published a final guidance on how sponsors can charge for new drugs under an investigational new drug application (IND) during clinical trials or in expanded access programs. Free ReportHow is the Biopharmaceutical industry evolving?
2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
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Source: Pharmaceutical Technology
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Source: Pharmaceutical Technology
Source: Pharmaceutical Technology
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The new guidance replaces a previous one issued in June 2016. If a sponsor wants to charge a trial participant for an investigational drug, the issued guidance provides a blueprint for the logistics involved in getting approvals for the same while ensuring it does not worsen any financial burden on participants. The updated document also outlines how this may work in a blinded, controlled clinical trial without compromising the study’s blind. In those cases, the FDA advised sponsors to seek out the appropriate review division in the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER) or get advice from the appropriate review office in the Center for Biologics Evaluation and Research (CBER) on how to maintain the blind. While the FDA allows sponsors to charge for a drug in a study after an authorisation, in terms of expanded access use, the agency mandates sponsors to give reasonable evidence that the charging would not interfere with drug development and provide documentation to justify this approach is consistent with current requirements.
The FDA also made it clear that sponsors must also show that the clinical trial would not be possible without asking for the costs to be incurred due to the extraordinary cost of the drug and providing the paperwork to support its calculation for cost recovery. The FDA lists potential reasons for extraordinary drug costs as “manufacturing complexity, scarcity of a natural resource, the large quantity of the drug needed (e.g., based on the size or duration of the trial), or some combination of these or other extraordinary circumstances.” The agency clarified that the “extraordinary” status of these costs would be assessed relative to the size of financial position of a company.
The FDA accepts several INDs every month in a bid to allow clinical research. Recently, the agency approved an IND from Veru for a Phase IIb trial investigating its GLP-1 RA-associated muscle loss drug Ostarine. This month, the agency also approved an IND for Acepodia’s solid tumour trial. The agency currently has a pre-IND consultation program in which sponsors can discuss any questions and concerns about the IND process with the FDA. See Also:FDA fast tracks Diamyd’s immunotherapy for managing type 1 diabetes Source: Pharmaceutical Technology
Japan’s FY 2024 pricing reform expected to favour new listed innovative drugs
Source: Pharmaceutical Technology
Free ReportHow is the Biopharmaceutical industry evolving?
2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects.
Benchmark the impact of major themes on the Biopharmaceutical industry.
Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents.
Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success.
Source: Pharmaceutical Technology
Antigua & Barbuda (+1268)
Bosnia Herzegovina (+387)
Cape Verde Islands (+238)
Central African Republic (+236)
Dominican Republic (+1809)
Sao Tome & Principe (+239)
Trinidad & Tobago (+1868)
Turks & Caicos Islands (+1649)
United Arab Emirates (+971)
Virgin Islands - British (+1284)
Virgin Islands - US (+1340)
Bonaire, Sint Eustatius and Saba
British Indian Ocean Territory
French Southern Territories
Heard Island and McDonald Islands
Saint Helena, Ascension and Tristan da Cunha
Saint Pierre and Miquelon
Saint Vincent and The Grenadines
South Georgia and The South
US Minor Outlying Islands
-->By downloading this case study, you acknowledge that GlobalData may share your information with GlobalData and that your personal data will be used as described in their Privacy Policy Submit
Visit our Privacy Policy for more information about our services, how GlobalData may use, process and share your personal data, including information on your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.
Thank you.You will recieve your mail in sometime.So, please check your email to download the Report.