This Week at the FDA: Hope for User Fee Reauthorization, EMA Says COVID-19 Pandemic Not Yet Over

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This week at the FDA

| September 23, 2022 | By Ferdous Al-Faruque

Welcome to another episode of This Week at FDA, your weekly source for updates — big and small — about the FDA, drug and medical device regulation, and what we’re reading on the web. The biggest development of the week is news that Congress may actually pass a user fee reauthorization bill. Regulators also released several important guidelines this week, including one on electronic submission of 510(k) applications.

While the US Food and Drug Administration has warned that it will have to lay off staff in the first half of September if Congress does not reauthorize its user fee programs, the agency does not has not yet done so, indicating his optimism that a bill will pass. before the carry-over funds are exhausted. This week, several news outlets reported that Senate Republicans and Democrats had reached an agreement to include a own reauthorization invoice in an interim spending bill that will allow user fee programs to continue after they expire on Sept. 30.

Although President Biden has said “the pandemic is overon CBS 60 Minutes on Sept. 18, his own health officials towed a more cautious line. Conversely, across the pond, the European Medicines Agency (EMA) said that the pandemic is underway and Member States must continue to operate on this premise.

The FDA has also released a number of important guidelines, including a long-awaited final directive on how to submit 510(k) requests electronically. After years of testing, the agency’s final guidelines are intended to help medical technology sponsors submit applications through the FDA. Electronic Submission Template and Resource (eSTAR) system by clarifying terminologies, processes and expectations.

The FDA has also issued draft guidance on ethical considerations when conduct pediatric clinical trials. It offers an ethical framework for protecting children in clinical research and explains the fundamental concepts of the ethical framework that Institutional Review Boards (IRBs), sponsors and industry should consider.

Another big story this week is that the FDA restarted surprise inspections of monitoring facilities that had been on hiatus since the start of the COVID pandemic. “In terms of (inspection) activity (in India), we are approaching pre-pandemic levels,” said Sarah McMullen, FDA Country Director – India. The economic period at a recent event in Mumbai.

Medicines and biologicals

The EMA has issued a statement this week confirming that all biosimilars approved in the European Union are interchangeable with other approved biosimilars referencing the same biologic, as well as with the reference biologic. This decision is part of the agency’s efforts to put regulators from different EU Member States on the same page.

FDA Commissioner Robert Califf told attendees of a webinar hosted by the agency’s Small Business and Industry Assistance (SBIA) program that they are looking for new ways to assess bioequivalence. and increase early interactions with industry to promote more undergraduate approvals of complex generics. One of the approaches the agency is considering is to develop alternative routes to assess a drug’s bioequivalence that would eliminate unnecessary human studies.

The FDA Vaccines and Related Biologicals Advisory Committee (VRBPAC) recommended that the agency approve a Fecal Microbiota Transplant (FMT) product manufactured by Rebiotix for recurrent Clostridium difficile (C. diff) infections. In a Ruling 13-4the external expert panel declared RBX2660 to be effective in treating patients with recurrent C. diff infections who have failed to respond to first-line antimicrobial therapy.

The FDA’s Oncology Drug Advisory Committee (ODAC) has voted 9 to 4 against approval Poziotinib from Spectrum Pharmaceuticals for the treatment of patients with a form of non-small cell lung cancer. The panel cited marginal efficacy, a high level of toxicities, and a lack of dose optimization in their decision. The company said it was disappointed and explore his options.

On the approval side, Trademark of Fennec Pharmaceuticals (sodium thiosulfate) has received FDA approval for the treatment of cisplatin-related ototoxicity in pediatric patients 1 month or older with non-metastatic solid tumors.

medical technology

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) released a report that the The FDA has repeatedly changed its Emergency Use Authorization (EUA) policies to meet the need for COVID-19 testing, resulting in inaccurate tests being brought to market. The report focused on FDA policies between January and May 2020, which included allowing developers to distribute tests before obtaining an EUA, if they notified the FDA and cleared the tests.

The FDA also announced this week that as part of its ongoing virtual public meetings on the development of COVID-19 tests, it will also answer questions about developing tests for monkeypox. The next town hall will be on September 28.

The FDA has issued a security alert for cybersecurity vulnerabilities on insulin pumps with wireless capabilities. This time the alert was for Medtronic’s MiniMed 600 series insulin pumps, where a vulnerability could allow malicious hackers to alter the dosage, which could lead to serious injury or death. So far, no adverse events have been reported associated with the vulnerability and Medtronic says hackers can only access devices if they are within a short distance of pumps.

© 2022 Society of Regulatory Affairs Professionals.

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