This Week: FDA warns two Chinese syringe makers, new guidances, upcoming meetings

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This week, FDA sent warning letters to two Chinese syringe makers for quality system violations, published several guidances, and announced upcoming public workshops.

In recent months, the US Food and Drug Administration (FDA) has issued several alerts, warning letters, and statements telling the public not to use Chinese-made plastic syringes that may have serious manufacturing problems unless there are no alternatives. Numerous companies have also initiated recalls of the affected syringes.

Now, FDA announced it has issued two more warning letters to Jiangsu Shenli Medical Production and Jiangsu Caina Medical for failing to ensure their syringes were made in compliance with quality system requirements. The agency added that users should not use enteral syringes made by Jiangsu Shenli Medical Production and should transition to other manufacturers, unless there are no alternatives available.

FDA published several guidances this week, including a final guidance on its regulatory requirements for determining donor eligibility for establishments that collect blood and blood components for transfusion or for further manufacturing use. The guidance also details circumstances where the agency will use its regulatory enforcement discretion for establishments that do not comply with the requirements.

FDA updated its final guidance on developing drugs to treat partial onset seizures to extend the document to patients as young as one month. The agency said that newer data from clinical studies showed that efficacy of the drugs used in adults could be extrapolated to young children.

The comment period for FDA's May draft guidance entitled, “Platform Technology Designation Program for Drug Development” has been extended until 28 August. The guidance originally had a 60-day comment period, but the agency has decided to add another 30 days after stakeholders said they needed more time to respond.

FDA also announced plans to publish a final guidance on investigational and licensed COVID-19 convalescent plasma by Monday. The guidance gives recommendations to blood establishments submitting Biologics License Application (BLA) for COVID-19 convalescent plasma intended for transfusion in patients with immunosuppressive disease or receiving immunosuppressive treatment.

Drugs & biologics

FDA announced it is looking to fill six vacancies on its Genetic Metabolic Diseases Advisory Committee but noted that one or more vacancies may already in the process of being filled. The chairperson position is one of the spots currently open on the committee.

The Center for Drug Evaluation and Research’s (CDER) plans to host a webinar to discuss the reorganization of its Office of Pharmaceutical Quality (OPQ). The agency plans to detail how the reorganization will streamline processes to make them more efficient, new technologies and tools to stay up-to-date with a changing regulatory environment, and plans to continuously improve its work processes.

FDA is hosting the 2024 Advancing Generic Drug Development Workshop as a hybrid meeting. Among the issues, agency officials plan to discuss the impact of the Generic Drug User Fee Amendments (GDUFA) Science and Research Program on generic drug development, regulation and drug approval.

Medtech

On 6 November, FDA plans to host a public workshop entitled “Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices” to update stakeholders on expanding its Accreditation Scheme for Conformity Assessment (ASCA) program to include chemical analysis to support biocompatibility of medical devices. The workshop will be held at the agency's headquarters in Silver Spring, MD, and webcast online.

DiaSorin Molecular received de novo authorization for its Simplexa C. auris Direct, a molecular-based assay used to detect Candida auris (C. auris) DNA from skin swabs to diagnose patients with C. auris infections. FDA said the test can help healthcare providers detect the infection faster than traditional culture-based techniques.

Baxter has issued a class I recall for its Life2000 Ventilator used to help patients breathe after reports of the battery charging dongle failing which could lead to the device not charging properly. The company said users should make sure there is an alternative to the device, check the charger dongle for damage, and if there is no damage, they should continue to use the device.

Bausch + Lomb and Synergetics initiated a class I recall for certain lots of their I-Pack Injection Kits used to deliver medicine into the eye after they were unable to verify that all the products had been properly sterilized. The companies are asking users not to use the products and have provided instructions on how to prevent their unintended use.

As Philips Respironics continuous to implement its class I recall of its OmniLab Advanced+ (OLA+) Ventilators used to help patients breathe, FDA said this week it is still evaluating the number of reports associated with the recall and plans to update the public as new information becomes available. The recall was initiated earlier this year after reports that the ventilator inoperative alarm on the devices was failing, which could prevent patients from getting treatment.

This Week: FDA warns two Chinese syringe makers, new guidances, upcoming meetings

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