FDA unveils new draft guidelines to help sponsors apply – Endpoints News

How does a cancer drug cross the FDA finish line 3-5 months before its PDUFA date? This is where real-time oncology review comes in.

Over the past five years, the Rick Pazdur-led FDA Oncology Center of Excellence has been quietly leveraged in RTOR to enable sponsors to provide even earlier, segmented submissions of critical efficacy and safety data, thus enabling these faster assessments of applications.

On Friday, OCE provided its first orientation project about the RTOR program, explaining how sponsors can apply, what to submit if accepted, and how RTOR is different from continuous exams, in that continuous exams require complete sections (e.g. the full clinical module) be submitted prior to the submission of a complete application.

“At the time the first results from one or more pivotal trials are available and the database has been locked, a candidate can request a review under RTOR by submitting an email request,” explains the agency. “Applicant must include their first results and a written rationale explaining how their application demonstrates that it is appropriate.”

Usually about 20 business days later, the FDA review division will decide if an application can be accepted.

While many drugs that have gone through RTOR so far have significantly reduced their PDUFA dates, the FDA also makes it clear in Friday’s draft that “this may not be feasible for all applications due to specific issues that can be identified with the application or overall workload considerations.

Generic and CRL Drug Manufacturers

Another burning issue for the agency is the fact that generic drugs often go through several rounds of reviews before being approved.

To help combat these long cycles of CRLs and new submissions, the agency released on Friday final direction explaining how if an ANDA applicant fails to fully remedy all deficiencies identified in a CRL, “within one year of issuance of the CRL (or take one of the other two actions prescribed by the regulations and described above), the FDA may consider this failure to be a request by the applicant to withdraw the ANDA.”

Regarding the changes from the draft released on September 29, 2020, the agency said:

Changes between the draft and the final guidelines include the addition of an appendix that provides [nine] examples of factors the FDA might consider as a basis for concluding that an applicant’s request for an extension of time to respond to a CRL is reasonable. In addition, editorial changes have been made to improve clarity.

Remote regulatory assessments outside of the pandemic

On Friday, the agency also released a new Q&A base orientation project on remote regulatory assessments, which have been an important resource for the agency during the pandemic, and will continue to be useful post-pandemic.

Although the agency explains how the FDA does not consider an RRA to meet the legal requirements for what an inspection (i.e. in-person assessment of a facility) is, it says that they are still useful, especially since the FDA has used them to help with approval. decisions, verify corrective actions for facilities with acceptable compliance status, and gain insight into the compliance of facilities that FDA was unable to inspect.

“The Agency believes that FDA’s use of voluntary and mandatory RRAs, as appropriate, for all types of FDA-regulated products is in the interest of public health, and the Agency is issuing these guidelines for provide greater transparency to stakeholders about the circumstances under which RRAs may be used both during and beyond the COVID-19 pandemic and promote greater consistency in how RRAs are conducted,” indicates the project.

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