FDA 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 hearing aids, the FDA Approval […]
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, 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 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 above-mentioned medical device product had […]
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 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 specific enforcement guidelines to support […]
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. […]
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