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Tag: medical products

FDA Proposes Removing Oral Phenylephrine as Active Ingredient in OTC Nasal Decongestants After Review

FDA Proposes Removing Oral Phenylephrine as Active Ingredient in OTC Nasal Decongestants After Review

In November 2024 the Food and Drug Administration announced its proposal to remove phenylephrine from the approved list of over-the-counter drugs to treat nasal congestion, citing evidence that the oral version of the drug is ineffective.

” FDA determines that Medical Device Registrations must be submitted electronically from October 2025″

ANVISA Publishes Database for Clinical Investigations into Medical Devices

In August 2024, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced that starting in October 2025, medical device manufacturers must use the eSTAR (Electronic Submission Template and Resource) model for submitting new registration applications.

Brazil’s Anvisa’s Medical Devices for In Vitro Diagnosis Regulation (RDC 830/2023) comes into force in June 2024

Anvisa's RDC 830/2023 Regulating Medical Devices for In Vitro Diagnosis comes into force in June 2024"

Anvisa’s RDC 830/2023 Regulating Medical Devices for In Vitro Diagnosis comes into force in June 2024

Ensuring the Thermal Integrity of Pharmaceutical Products in Brazil

"Anvisa updates the labeling of cosmetic products"

Brazil’s Anvisa, legislation provides guidance on the qualification of the transportation of biological products in bulk in their primary and finished packaging.

Consultations Meetings with Anvisa – Health Products

Scheduling your Meeting Consultations with Anvisa: Brazilian System-Parlatory

Scheduling your Meeting Consultations with Anvisa: Brazilian System-Parlatory

Mexico’s Cofepris Submits preliminary draft amendment of the Health Products Regulation

On April 7th, Cofepris submitted a preliminary draft amendment on Heath products regulation with the goal to optimize current practices based on best practices of international regulatory agencies.

Do You Qualify for FDA Emergency Use Authorization (EUA) for Coronavirus (COVID-19)?

If you are a Medical Device, or Pharmaceutical that has the potential to diagnose or treat Coronavirus, you may qualify for FDA Emergency Use Authorization (EUA) in USA.

FDA publishes guidance on conducting clinical trials during COVID-19 Pandemic.

On March 18, 2020, FDA made widely available a new Guidance Document on managing clinical trials during the COVID-19 pandemic.

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