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117 results found for: fda
FDA approves Leqvio injection as a treatment and tolerated statin therapy for the patients who require additional lowering of low-density lipoprotein cholesterol commonly known as LDL-C. Leqvio injection works to reduce levels of LDL-C in the body, commonly known as […]
The U.S. FDA has revised the EUA authorizing REGEN-COV for emergency use as post-exposure prophylaxis for prevention of Coronavirus (Covid-19) in adults and pediatric individuals, who are at high risk for progression to severe COVID-19. REGEN-COV is not authorized for […]
On 18th October, 2021 FDA issued a public notice stating it approves ZIMHI injection. ZIMHI injection as an additional option to treat opioid overdose around the world. ZIMHI(naloxone hydrochloride) is administered using a single-dose and its prefilled syringe delivers 5 […]
The SFDA Registrations has issued a revised version of MDS-G25, Guidance on Requirements for Storage, Handling and Transportation of Medical Devices. It was initially released in 2018, however, SFDA has revised it including 2 additional points – Instruments measuring temperature […]
A discussion paper has been published by the US FDA Medical Device Regulations focussing on vulnerability and cybersecurity issues where companies from the industry can comment until August 17, 2021. The main aim of this report is to strengthen and […]
On 30th June, 2021, The US FDA removed the access for COVID-19 related Emergency Market Access for certain types of medical devices and personal protective equipment (PPE) as there has been a greater supply locally for these products. The EUA […]
Due to the wide outspread of COVID-19, healthcare systems have been highly overwhelmed. There has been a challenge to effectively deliver Medical Care and Support to Patients worldwide. The US FDA has issued emergency authorizations for IVD Test Kits, PPE […]
The US FDA in August 2020, published a notice to re-classify non-invasive bone growth stimulators. The category included products generating magnetic and electric fields, devices that use CC, CMF, Ultrasonic Waves and PEMF. This re-classification was introduced to increase the […]
Maharashtra Food and Drug Administration (FDA) has directed all 306 blood banks in the state to submit applications of renewal of licenses by 31st December 2016 to carry out timely inspections and approvals. There are around 53 blood banks in […]
Recently antibacterial soaps banned in US by Food and Drug Administration (FDA) amid claims they do more harm than good. US FDA banned the use of certain compounds in antibacterial hand and body wash products. India’s CDSCO (Central Drug Standard […]