Jun 5, 2020
Canada
The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, issued a compliance program describing the inspections related to CDER-led or CDRH-led combination products. The document provides the requirements for different...
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Nov 26, 2019
Asia
The Medical Device Authority (MDA), Malaysia’s agency for regulating medical device manufacturing, importation, and distribution, issued guidelines for the registration of drug-device and device-drug combination products. Current Regulation for Drug Medical Devices...
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Sep 20, 2019
North America
The FDA has finalized a guidance about citizen petitions against the approval of drugs, which delays the application process, and what they look for in petition submissions as well as why submissions might be denied. This comes after the abundant number of false...
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Sep 5, 2019
India
Experts and pharmaceutical companies in India may grant terminally ill patients access to drugs that have not yet been cleared through clinical trials. The new policy would serve as a last resort for patients who are left with no available approved treatments. A draft...
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Jul 8, 2019
EU MDR/IVDR
On Friday, the European Medicines Agency (EMA) released two guidance documents addressing issues surrounding drug shortages in the EU, and how to manage drug shortages publicly. These documents were created by a task force specifically to aid in companies’ reporting...
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