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Channel Posts
** SOPP 8401: Administrative Processing of Original Biologics License
Applications (BLA) and New Drug Applications (NDA) **
Download here: https://www.fda.gov/media/88774/download?attachment
| 2 | **SOPP 8201: Administrative Processing of Clinical Holds for
Investigational New Drug Applications**
Download here: https://www.fda.gov/media/88774/download?attachment | 2 199 |
| 3 | CBER revises internal procedures for processing clinical holds, NDAs and BLAs
The US Food and Drug Administrationâs Center for Biologics Evaluation and Research (CBER) has published two internal policy guides for staff outlining procedures for placing a clinical study on hold and addressing the administrative processing of biologics license applications (BLAs) and new drug applications (NDAs).
Both sets of policies went into effect on 22 September 2023.
Processing clinical holds
Standard operating policy and procedures (SOPP) 8201, version 8, covers the administrative processing of clinical holds. Under 21 CFR 312.12, clinical holds are ordered by FDA when a clinical investigation reveals information that indicates a proposed treatment poses an "unreasonable and significant risk of illness or injury" while under 21 CFR 312.42(e), the clinical hold can be lifted if the agency is satisfied that these risks have been addressed.
Under the policy, CBER will review all investigational new drug applications (INDs) within 30 days of receipt and contact the sponsor when a clinical hold is being imposed. The policy states that âwhere it is determined there are grounds for imposing a clinical hold, regulations require that, unless patients are exposed to immediate and serious risk, FDA will attempt to discuss and satisfactorily resolve the matter with the sponsor before issuing the clinical hold order.â
The latest version updates version 7, which was issued in June 2022, and adds new language on imposing a hold when a sponsor stops a study for safety reasons and is investigating. The version 8 SOPP also updates procedures to include letter issuance for an incomplete response to a clinical hold and a clinical hold memo template for active INDs.
BLAs and NDAs
The second procedures guide, CBER SOPP 8401 version 17, covers the administrative processing of BLAs and NDAs that are subject to fees under the Biosimilar User Fee Act (BsUFA) and the Prescription Drug User Fee Act (PDUFA). The guidance also covers applications for non-user fee products.
The guide outlines procedures governing the receipt of applications, requirements for electronic submissions, review timelines, timeline extensions, reviewing unsolicited amendments, reaching milestones for mid- and late-cycle meetings, and timelines for advisory committee meetings.
The SOPP addresses the definitions of a major amendment, unsolicited amendments, a complete response letter, the deficiencies identified in a Day 74 letter, an establishment inspection report (EIR), expedited letters, and what constitutes a substantive review issue. Additionally, the document covers the responsibilities of the review committee in resolving scientific issues.
The guide states that âapplications filed over protest after a refuse to file decision are not eligible for parameters of the PDUFA Program. The original submission will be subject to the review goals per the current PDUFA goals letter; resubmission goals do not apply.â In these cases, the guide directs staff to consult SOPP 8404.1: Procedures for Filing an Application when the Applicant Protests a Refusal to File Action (File Over Protest).
The revision supersedes version 16 by adding a new Refuse-to-File briefing and clarification related to communications for deficiencies identified during filing review. | 2 116 |
| 4 | FDA guidance on formal meetings adds new categories, timelines
The US Food and Drug Administration (FDA) has issued revised draft guidance to help sponsors understand the different types of meetings they can request for questions related to their applications and describes the timelines associated with these requests.
The guidance incorporates the agreements reached between FDA and industry in the Prescription Drug User Fee Act (PDUFA) VII negotiations.
The guidance, announced in the Federal Register on 21 September 2023, adds two new types of meetings, a Type D meeting for topics of narrow interest and meetings through the INitial Targeted Engagement for Regulatory Advice on CBER ProducTs (INTERACT) pathway for new and innovative technologies. It also now classifies video conference meetings as virtual face-to-face meetings.
The guidance was jointly issued by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). It does not cover abbreviated new drug applications (ANDAs), applications for biosimilar biological products, or medical device submissions.
This draft guidance replaces an earlier version issued in December 2017 (RELATED: Formal Meetings Between FDA and Biopharma Companies: New Draft Guidance, Regulatory Focus 2 January 2018).
Meeting types
The guidance describes the different meeting categories: Type A, B, C and Type D and INTERACT meetings.
Type A meetings are for products with stalled development programs or for resolving disputes. Type B meetings include pre-investigational new drug applications (pre-IND) meetings or for certain end-of-phase I meetings (EOP).
Type C meetings are reserved for issues that do not fit in these categories and can be used to consult on the use of a biomarker as a new surrogate endpoint that has never before been used.
The revision adds a new Type D meeting and INTERACT meetings. Type D meetings are âfocused on a narrow set of issues that are used to discuss issues at key decision points to provide timely feedback critical to move the program forward.â These can include follow-up questions that raise a new issue after a formal meeting. These meetings should be limited to no more than two focused topics, according to FDA. The agency must respond to requests for Type D meetings within 14 days and schedule a meeting within 50 days of the request.
INTERACT meetings are reserved for ânovel products and development programs that present unique challenges in early development.â These can cover questions related to the design of IND toxicity studies and complex manufacturing technologies or processes. FDA must respond to requests for INTERACT meetings within 21 days and schedule a meeting within 75 days of the request.
The guidance also adds video conference meetings (called âvirtual face-to-faceâ) to the three other meeting formats, joining face-to-face meetings, teleconferences and written response only (WR) where written responses are sent in lieu of virtual or face-to-face meetings. | 2 058 |
| 5 | Swissmedic updates guidance on temporary medicine authorization to harmonize deadlines
The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on the temporary authorization of human medicinal products.
In the document, Swissmedic outlines the process for seeking temporary authorization, a path to market that allows organizations to sell a medicine for up to two years despite lacking complete documentation. Switzerland uses temporary authorization to accelerate access to treatments for life-threatening diseases, enabling patients to receive therapies while the developer works to meet the full approval requirements.
Swissmedic recently updated its advice on temporary authorizations, publishing version 13.0 of the guidance and revising an associated question-and-answer document. Most of the advice is unchanged, meaning the focus remains on the requirements and submission process for temporary authorization, but Swissmedic has clarified its position on several points.
The temporary authorization pathway is only open when there is no alternative or equivalent medicinal product authorized in Switzerland in the target indication. Swissmedic used the update to its guidance to reduce potential confusion about when it deems a product to be âauthorized.â A product is authorized if it has come to market via the standard procedure or been converted from a temporary authorization.
Swissmedic has also harmonized its application deadlines for temporarily authorized medicinal products. The change means companies need to submit all documentation to Swissmedic at least 90 days before the expiration of a temporary authorization, regardless of whether they want to remove the conditions on their authorization, apply for an extension, or request a waiver.
Officials also made a terminology change. Previously, Swissmedic used the term âordinary authorizationâ to refer to the standard approval that companies can seek if they fulfill the requirements set by the agency. Now, Swissmedic has changed to the term to âauthorization without special conditions.â Products converted from temporary authorizations will now be deemed to have authorization without special conditions.
The changes are reflected in an updated question-and-answer document. Swissmedic has revised four of its answers and responded to two new questions about the conversion of temporary authorizations.
In response to one question, Swissmedic explained that it is not possible to convert a temporary authorization to an export license. The agency justified its position on the grounds that a therapeutic can only be temporarily authorized if âno authorized, alternative or equivalent medicinal product is available in Switzerland.â Swissmedic underlined âin Switzerlandâ to show the law only applies to local use.
The second new question addresses what happens to therapeutics with temporary authorization when an equivalent product is eligible for conversion to an authorization without special conditions. In that situation, Swissmedic will not allow the companies to apply to extend the temporary authorizations of the equivalent products. Swissmedic could still extend the authorization itself in some circumstances.
âSwissmedic may require more than the remaining time until expiry of the temporary authorization to review the documentation on the fulfillment of conditions,â the agency wrote. âIt therefore extends the temporary authorization as necessary following receipt of the documentation on the fulfillment of conditions.â | 1 504 |
| 6 | *FDA releases guidance on labeling of drug use-related software outputs*
The US Food and Drug Administration (FDA) has released draft guidance with considerations on how to include software outputs of drug use-related software in prescription labeling.
In the draft guidance, FDA defines prescription drug use-related software as including software disseminated by the drug sponsor or an entity acting on behalf of a sponsor that creates an end-user output that âsupplements, explains, or is otherwise textually related to one or more of the sponsorâs drug products.â The agency said it considers end-user output from drug-related software as a type of prescription drug labeling.
FDA initially opened a docket in November 2018 to seek public comments on a proposed framework for regulating software applications related to prescription drug products.
Comments from stakeholders -- which included pharmaceutical companies, trade associations, digital health companies, and coalitions -- were generally supportive, but called on FDA to align the prescription drug-use-related software framework with regulatory initiatives in the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH) (RELATED: Industry Seeks Cross-Center Alignment in FDA Proposal on Prescription Drug Software, Regulatory Focus 02 April 2019).
The draft guidance, which was released on 18 September 2023, was created in response to public comments about the framework, according to FDA (RELATED: FDA Proposes New Framework on Prescription Drug-Related Software, Regulatory Focus 19 November 2019).
In the draft guidance, FDA said the recommendations are intended to align with initiatives âacross all product centers,â including CDRH digital health initiatives, and is not an alteration of the current regulatory framework. âRather, it focuses on the application of drug labeling authorities to the end-user output of prescription drug use-related software, regardless of whether such software is regulated as a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act),â the agency wrote.
The agency said its focus for now is on oversight of functions for drug-related software where there is a ârisk to a patient's safety if the device were not to function as intended.â While there may be instances where end-user output of software functions is considered a device, FDA believes âa significant proportionâ of output will be direct information to a patient about use of a prescription drug.
The draft guidance includes specific recommendations about what to include in the prescribing information for drug use-related software, including a summary of the âessential scientific information needed for the safe and effective use of the drug productâ and information on the drug and device constituent part for combination products. The guidance notes that a description of device-connected software functions and end-user output of the device-connective software functions should typically be included. Additionally, the information âshould be consistent with the general approach usedâ for prescribing information, FDA advised.
Drug sponsors with products that have drug use-related software that leads to a clinically meaningful benefit can propose including that data on the prescribing information, while sponsors who have not submitted evidence of clinically meaningful benefit from drug use-related software, such as with combination products, can include a description of the relationship between the software and the device. In the latter case, âinformation beyond describing the device constituent part and associated software function(s) or statements suggesting a clinical benefit should not be included,â the agency said.
End-user output data and updates to end-user output functionality in the software that are considered promotional labeling should be submitted at the time of dissemination, but security updates and other software updates that do not alter | 1 446 |
| 7 | https://www.raps.org/News-and-Articles/News-Articles/2023/6/FDA-drafts-guidance-to-aid-orthopedic-implant-guid | 3 387 |
| 8 | https://www.raps.org/news-and-articles/news-articles/2023/6/fda-issues-first-psychedelic-drug-trial-guidance | 3 260 |
| 9 | https://www.raps.org/News-and-Articles/News-Articles/2023/6/Euro-Roundup-MHRA-clarifies-interim-approach-for-U | 3 730 |
| 10 | https://www.raps.org/News-and-Articles/News-Articles/2023/6/FDA-seeks-feedback-on-ICH-E6(R3)-GCP-guideline | 4 332 |
| 11 |  No text... | 4 635 |
| 12 | https://www.raps.org/News-and-Articles/News-Articles/2023/5/FDA-finalizes-guidance-on-adjusting-for-covariates | 4 177 |
| 13 | https://www.raps.org/news-and-articles/news-articles/2023/5/this-week-at-fda-fda-appropriations-markup-delayed | 3 645 |
| 14 | https://www.raps.org/news-and-articles/news-articles/2023/5/e6(r3)-ich-releases-draft-of-overhauled-gcp-guidel | 3 484 |
| 15 | https://www.raps.org/news-and-articles/news-articles/2023/5/fda-drafts-guidance-on-using-%E2%80%98generally-accepted%E2%80%99 | 3 524 |
| 16 | https://www.raps.org/News-and-Articles/News-Articles/2023/5/Dual-draft-guidances-outline-FDA-vision-for-pediat | 3 037 |
| 17 | https://www.raps.org/news-and-articles/news-articles/2023/4/imdrf-guidances-address-cybersecurity-personalized | 4 503 |
| 18 | https://www.raps.org/news-and-articles/news-articles/2023/4/euro-roundup-transition-to-mdr-underway-for-63-of | 4 016 |
| 19 | https://www.raps.org/news-and-articles/news-articles/2023/4/fda-sheds-light-on-criteria-for-approving-pais-bas | 3 444 |
| 20 | Medical Product Alert No. 3/2023
Falsified DEFITELIO (defibrotide sodium) identified in the WHO Regions of Europe and the Eastern Mediterranean | 3 030 |
