FDA 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, biologics, and devices. The government […]
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 MDR) from May 26, 2024, […]
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 the FDA has not approved […]
Read MoreFirst Respiratory Syncytial Virus (RSV) Vaccine Approved by FDA
This article deals with the first respiratory syncytial virus (RSV) vaccine approved by the FDA Medical Device Regulation. Arexvy is the first respiratory syncytial virus (RSV) vaccine that the FDA Medical Device Regulation has licensed for use in the country. […]
Read MoreDual-Labelled Names to Transition to Sole Names by TGA
This article deals with the changes to the dual labelling period as of April 30, 2023, by TGA Australia. The labels, Product Information (PI), and Consumer Medicines Information (CMI) papers are now requesting dual labelling for multiple ingredient names used […]
Read MoreEvaluation of Automatic Class III De Novo
This article deals with the classification of medical devices under the De Novo Pathway. Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically […]
Read MoreTGA Australia New Powers can help decrease patients exposure to medicine shortages.
The Australian Registry of Therapeutic Goods (ARTG) has made measures to help patients deal with the consequences of medication shortages, including the temporary import or supply of an internationally licensed pharmaceutical in place of one that is in limited supply. […]
Read MoreFDA Risk Classification on toxic compound exposure while using dialysis devices
This article deals with the FDA risk classification continued evaluation of the potential risk of hazardous chemical exposure when utilizing dialysis devices. The FDA has issued a letter to health care providers to assess the risk of exposure to non-dioxin-like […]
Read MoreNMPA certifies third batch of medical equipment
This article discusses NMPA Certification the decision to implement unique identification of medical devices for some Class II medical devices in order to continue implementing the Regulations on the Supervision and Administration of Medical Devices, the Notice of the General […]
Read MoreBans on Medical Devices by FDA Medical Device Regulations
Bans on Medical Devices by FDA A medical device ban is a complete restriction on all present and future production, distribution, and sales of medical devices if the FDA Medical Device Regulations believes that a medical device intended for human […]
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