Engagement 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 […]
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 […]
Read MorePhilippines FDA Regulations Warns Against Purchasing and Using Unnotified Medical Devices
This article deals with the Food and Drug Administration (FDA) regulations warning all healthcare professionals and the general public not to purchase and use unnoticed medical device products such as The FDA regulations confirmed that the […]
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 […]
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 […]
Read MoreFDA Guidelines for COVID-19 Related Medical Device Transition Plans.
The Center for Devices and Radiological Health (CDRH) of the FDA has released two final guidance documents to help with transition plans for medical devices that have received Emergency Use Authorizations (EUAs) or fall under […]
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 […]
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 […]
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