This week at the FDA: Bardoxalone takes on adcomm; Updated device consensus standards

Happy Friday – this week we’re juggling a lot of US Food and Drug Administration (FDA) year-end activities. Today and next week, look for our contributors to highlight several draft and final guidance documents and to provide analysis and context on industry reactions to other guidance which comment periods have recently had. ended.

The Center for Drug Evaluation and Research (CDER) today published its update on regulatory scientific news for fall / winter 2021. The 6-page newsletter provides updates on actions related to COVID-19, such as updates to Emergency Use Authorizations (EUA) for therapies to treat the virus, and includes a reminder not to use ivermectin deworming treatment for treat COVID-19. Highlights of recently published research by CDER authors, a notice of job and internship opportunities with CDER, and a summary of three “impact stories” complete the newsletter.

The FDA also gave its policies and procedures manual (MAPP), Conducting Effective Meetings in CDER: Remote Access Considerations, a post-pandemic refreshment. The revised MAPP now notes the agency’s pandemic procedures to limit social gatherings in the workplace and replaces the reference to WebEx, Adobe and Skype by MS Teams and ZoomGov for hosting meetings.

Two new draft guidance documents have reached the Office of Management and Budget (OMB) for review, signaling their possible release in the near future if the White House approves the documents. The guidelines cover the development of non-opioid analgesics for acute pain and the notification to the agency of medical device shortages and interruptions under section 506J of the Federal Law on Food, Drugs and Cosmetics.

CDER this week published a case study showing how physiological pharmacokinetic (PBPK) modeling of bioequivalence (BE) can support FDA approval of a topical generic drug. In the case study, the modeling approach supported the approval of generic diclofenac sodium topical gel on the basis of an “alternative BE approach instead of the comparative BE study on clinical endpoints” would normally recommend the FDA.

The agency updated its compendium of clinical outcome evaluations (ACOs), “to encourage the development and implementation of patient-focused clinical outcome evaluations” for use in clinical trials. The latest updates include COAs for new molecular entity and biologic license application labels from July 2017 to June 2018, as well as efficacy supplements through June 2018 and CDER qualified measures.

Adcomms and permissions

An FDA advisory committee has unanimously approved Reata’s methyl bardoxalone for the treatment of chronic kidney disease caused by Alport syndrome. The Cardiovascular and Renal Drug Advisory Committee cited, among other considerations, safety concerns and the selection of estimated glomerular filtration rate as the primary endpoint in the pivotal phase 3 trial.

At time of going to press, the CDRH Medical Device Advisory Committee Neurological Device Expert Group meeting is underway. The committee is considering a pre-market approval application for BrainsGate’s ischemic stroke system, designed to increase blood flow to the brain in certain patients with acute ischemic stroke who cannot receive intravenous anticoagulants or endovascular thrombectomy.

Also this week, the FDA cleared a new combination of monoclonal antibodies for emergency use as pre-exposure prophylaxis against COVID-19 in certain immunocompromised people and people who are not recommended to receive COVID vaccines. -19. Evusheld by AstraZeneca (tixagevimab co-packaged with cilgavimab and administered together) is administered by intramuscular injection and is approved for children 12 years of age and older in the indicated population.

The app corner

On the law enforcement side, the FDA last month released a warning letter to Kentucky-based Induction Therapies, LLC regarding its promotion of an unauthorized micro-needle device. Despite the company’s claim that its “Collagen PIN is an FDA-registered Class 1 medical device for percutaneous collagen induction therapy,” the FDA claims that the device was distributed without approval, authorization or authorization and that it is both falsified and mislabeled.

The agency also released a 483 that it handed to generic drug maker Dr Reddy, detailing eight sightings identified during an inspection of the company’s Duvadda plant in Andhra Pradesh, India. The 483 notes issues with the company’s adherence to quality control procedures, laboratory controls, and validation of tests performed by its suppliers. He also notes issues with the site’s aseptic processing areas and microbial contamination prevention procedures.


In device news, the FDA this week updated its list of recognized consensus standards for medical devices, adding, removing or amending dozens of standards on the list. Device manufacturers may choose to declare compliance with recognized standards to meet certain requirements of their devices as part of pre-market review submissions or for other purposes.

The CDRH has published a list of COVID-19 tests that could be impacted by the omicron variant. The center highlights two tests, the Revogene SARS-CoV-2 tests from Meridian Bioscience and Tide Laboratories DTPM COVID-19 RT-PCR, with a reduced ability to detect the variant. It also indicates that 26 tests with abandonment of the S gene can be affected by the omicron variant. “A specific deletion in the spike (S) gene (Δ69-70) results in dropout of the S gene, also called S-gene target failure (SGTF), where the genetic target that covers the part of the S -gene where the deletion occurs fails to detect the virus, ”says the CDRH.

The agency also issued a final order denying a petition to exempt Class II “motorized patient transport devices, all other motorized patient transporters” regulated by the ILK product code of 510 (k) requirements.

In addition, the FDA continued its streak of de novo classifications of devices, by issuing final orders classifying five devices in class I and class II. The devices include pressure ulcer management tools, temporary roll-up embolization aids, ingested, transient, space-occupying device for weight management and / or weight loss, pressure relief device. negative pressure wound therapy for reduction of wound complications and transcutaneous electrical nerve stimulation for attention deficit hyperactivity disorder. disorder.

The FDA has published the report of three rounds of negotiations around the re-authorization of the Changes to fees for the use of medical devices (MDUFA V) this week. The minutes from the May and June meetings recount discussions on the FDA’s calculations regarding its staffing needs, how the additional COVID-19 funding will be used, and where industry believes MDUFA resources could be used in the future. better at the FDA. The minutes, more detailed than those of most user fee negotiation meetings, are interesting to read.

What else do we read

This story in Fierce health care which cites a recent Deloitte report on physician attitudes toward wearable health technologies. Doctors and other healthcare providers cite lack of interoperability and concerns about accuracy as persistent reasons for skepticism about how wearable devices can be integrated into healthcare delivery.

As reported today in FocusThe FDA faces a surge in cell and gene therapy requests, but continues to fight chronic staff shortages that are in large part attributable to wage differentials between the federal and private sectors. The agency’s Center for Biologics Evaluation and Research (CBER) this week posted a job posting for a cell and gene therapy examiner, imploring applicants to “become a member of an agency that touches the lives of every American.” ! Candidates prepared for the doctorate are encouraged to apply for the staff member position.

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