FDA Approval For Wound Treatment in Epidermolysis Bullosa
Vyjuvek, a herpes simplex virus type 1 (HSV-1) vector-based gene therapy, has been given approval by the FDA for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) who have mutations in the […]
Read MoreCosmetic Medicine Are Now Under Stricter Regulation
A guideline to strengthen oversight of the medical cosmetology industry was recently released by eleven central departments, including the State Administration for Market Regulation, the National Health Commission, and the Ministry of Public Security. The […]
Read MoreFDA Approved for Drug To Treat Alzheimer’s Agitation Symptoms with Dementia
The FDA approved Rexulti (brexpiprazole) oral tablets are supplementary approval for the treatment of agitation associated with dementia caused by Alzheimer’s disease. This is the first therapy option for this indication that has FDA Approved. […]
Read MoreMeasures are Taken To Enhance Healthcare.
China’s most recent policy or regulation initiatives to strengthen its national healthcare service system will facilitate the provision of high-quality healthcare services at the community level, assist in resolving issues that these regulation concern the […]
Read MoreFDA Approval for OTC Hearing Aids
Hearing loss affects 30 million adults in the US, with a high number of people affected by it. Only one-fifth of those who could benefit from a hearing aid seek intervention. To increase access to […]
Read MoreFDA Regulations Advance Decentralized Clinical Trials
The FDA Regulations is adopting further measures to facilitate the use of decentralized clinical trials (DCTs), in which part or all trial-related activities take place at places other than conventional clinical trial sites, including medicines, […]
Read MoreThe EU MDR Extended Transition Period is Acknowledged By The TGA Regulations
This article deals with the TGA regulations will acknowledges the prolonged transition period for the EU Medical Device Regulation. The EU extended the EU MDR transition period (external site for devices moving to the EU […]
Read MoreEngagement of Consultant Companies for FDA Business
The FDA is aware that a number of businesses or individuals provide services linked to FDA rules, such as helping with product approvals or offering guidance on regulatory compliance. It is important to remember that […]
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