The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA: Curative test for COVID should be conducted per product label; FDA posts MEA final guidance; CMS eyes radiology quality measures; Ra Medical agrees to fines.
HONG KONG – Hutchison China Meditech Ltd. (Chi-Med) earned approval from China’s National Medical Products Administration (NMPA) for Sulanda (surufatinib) for the treatment of non-pancreatic neuroendocrine tumors (NETs), marking what CEO Christian Hogg called a “major milestone” as the first drug to be discovered and developed by Chi-Med without the support of a development partner.
The U.S. Department of Health and Human Services (HHS) released an advisory opinion last week saying that drug manufacturers are obligated to provide 340B pricing for outpatient drugs dispensed by contract pharmacies on behalf of hospitals and clinics that qualify for the discounts. But the opinion said nothing about enforcement action or assessing civil penalties against manufacturers who refuse to do so.
NEW DELHI – The Drugs Controller General of India (DCGI) granted its first emergency conditional approvals Jan. 3 for a pair of COVID-19 vaccines, including Covishield, developed abroad by Astrazeneca plc and Oxford University and manufactured by the Pune-based Serum Institute of India (SII). The DCGI also approved Covaxin, which was developed locally by Hyderabad-based Bharat Biotech International Ltd. in collaboration with the Indian Council of Medical Research, and is still in phase III trials.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ambrx, Antengene, Arcturus, Atara, Ayala, Bioniz, BMS, Forge, Inozyme, Matinas, Opko, Passage, Pfizer, Provention.
As is the case with many national governments, the U.S. federal government does not routinely measure its activities in the calendar year, but we at BioWorld don’t share that outlook. CY 2020 was odd in more ways than one from a regulatory standpoint, and thus we offer our version of a regulatory top 10 for a year that might not look much better in the rear-view mirror than it has looked as a current event.
The U.S. FDA has granted emergency use authorization (EUA) to Quanterix Corp.’s SARS-CoV-2 IgG antibody test, which tests blood samples for evidence of recent or prior COVID-19 infection. The test could also be used to measure antibody response to a COVID-19 vaccine. The Simoa Semi-Quantitative SARS-CoV-2 IgG antibody test is indicated for the qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and dipotassium EDTA plasma from a venous blood draw.
A new rule intended to give drug manufacturers the flexibility they need to enter into value-based purchasing agreements with state Medicaid programs and commercial payers could end up hurting patients at the pharmacy counter in the U.S.
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