Unique Device Identification Rules, SFDA
The Saudi Food and Drug Authority (SFDA), Saudi Arabia’s Medical Device Regulator has pushed the enforcement of the Unique Device Identification by a year in phases. The SFDA bought in these regulations on 1st October, 2020. The new dates are […]
Read MoreOTC Drugs New Publication
This article deals with the new gazette which talks about OTC Drugs. This article was released on 25th May, 2022. Any objection or suggestion must be given to the Government within 30 days for it to be taken into consideration. […]
Read MoreSoftware as Medical Device Update by TGA
The following article deals with the latest update for Software as Medical Device by The Australian TGA (Therapeutic Goods Administration). Software based Medical Devices (SaMD’s) are regulated by the TGA and must be included in the Australian Register of Therapeutic […]
Read MoreCDSCO (G.S.R 877(E) – Drugs & Cosmetics Act (Amendment) Rules, 2021
This news deals with the latest Amendment which has been published by the CDSCO. The CDSCO has released a new Amendment in the Drugs and Cosmetics Act, 1945 with Notification number S.O.877(E) published on 23rd December,2021.The Draft rules for amendment […]
Read MoreBiogen get’s US FDA fast track designation for lecanemab
Eisai.Co.Ltd and Biogen has announced that lecanemabs is an investigational anti-amyloid protofibril antibody for treatment of AD(Alzheimer’s Disease) and the US FDA has granted Fast Track designation for it. Earlier FDA had granted Breakthrough Therapy designation for lecanemabs in June,2021. […]
Read MoreUS FDA Approves Add-on therapy to Lower Cholesterol Among Certain High-Risk Adults
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 […]
Read MoreCovishield Booster Dose
The CDSCO and The Subject Expert committee has informed that COVID -19 booster dose cannot be recommended or used without clinical trials. The Serum Institute had given an application for Booster Dose of Covid-19 on December 9th, 2021 to the […]
Read MoreExtension in Shelf Life for Import of Medical Devices, India
The CDSCO has published a special condition under which the permission for Import of drugs with residual shelf life less than 60% is extended until next year. Due to the COVID-19 situation, the effective date of the circular dated on […]
Read MoreSynthetic Tissue with Medical Consultancy.
People who are recovering from heart damage often face a long journey. Due to constant movement tissues are as the heart beats more challenging in the healing process, the same is for vocal cords also. Until now there was no […]
Read MoreRegulatory Compliance for ALS Therapy
This News article deals with the Regulatory Compliance for ALS Therapy The Brain is a target for treating ALS (amyotrophic lateral sclerosis). Northwestern Medicine Scientists have discovered that the disease starts in the spinal neurons and would need to target […]
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