PharmaCyte Biotech Inc. (OTCMKTS:PMCB) has announced that the FDA’s Centre for Devices and Radiology Health has issued it with Medical Devices Establishment Registration. The registration is vital to companies planning the importation of medical devices from abroad.
PharmaCyte gets Medical Devices Registration For COVID-19 tests and files Pre-EUA
The biotechnology company has established itself as the main Hai Kang Life Corporation Limited agent in the US to import coronavirus in vitro test kits. Equally, PharmaCyte is planning to sell its PCR diagnostic test kits to laboratories across the US that are certified by Clinical Laboratory Improvement Amendments.
Also, the company has announced that it is in discussion with the FDA regarding a Pre-Emergency Use Authorization application to the FDA. With the submission, it means the FDA can accelerate the approval of new medical devices and drugs during a national emergency. The FDA has recommended that for the SARS-CoV-2 devices, suppliers and manufacturers can submit a Pre-EUA to work interactively towards EUA approval. According to the FDA, companies should file a draft earlier so that the FDA examiner can give them feedback to do away with unwanted delays when reviewing the final EUA.
PharmaCyte’s consultant carrying a final audit on its LAPC clinical trial product
The company has also announced that its GMP consultant, cGMP Validation, is carrying a final audit of its Thailand manufacturing facility, where company’s its Austrianova Singapore manufactured clinical study product. Once the audit is finalized, cGMP Validation will approve the importation of the product by PharmaCyte to its US supply chain dealers for storage at -80C until the time it will be required.
Interestingly cGMP Validation and Austrianova have now finalized their work. They have achieved what has been considered as compliant batch records for cGMP in two successful production runs from Austrianova. The companies collaborated to review the batch records produced during the two successful production runs that resulted in PharmaCyte’s clinical study product for the expected Phase 2b clinical study in inoperable locally advanced pancreatic cancer (LAPC).