Top Strategies to Avoid Costly FDA Submission Mistakes in 2025
Discover expert tips to avoid costly FDA submission mistakes in 2025. Learn how to ensure compliance, improve documentation, and accelerate product approval.
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Category: FDA
Regulatory Pathways for Medical Devices: EU MDR vs. FDA 510(k)
EU MDR vs. FDA 510(k) Medical device manufacturers aiming for global market access must navigate complex regulatory frameworks to ensure compliance. Two of the most critical regulatory pathways are the European Union Medical Device Regulation
Read MoreFDA Approves First Gene Therapy for Aromatic L-amino Acid Decarboxylase (AADC) Deficiency: A Landmark in Rare Disease Treatment
IntroductionThe U.S. Food and Drug Administration (FDA) has recently approved a ground-breaking gene therapy for the treatment of Aromatic L-amino Acid Decarboxylase (AADC) deficiency, marking a significant advancement in the field of genetic disorders. This
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Important Regulatory Changes in USFDA for Pharma Companies in 2024 to File an NDA
The USFDA’s 2024 regulatory changes At Vigilare Biopharma, we understand the complexities and challenges that pharmaceutical companies face when navigating the ever-evolving regulatory landscape. The USFDA’s 2024 regulatory changes reflect a significant shift towards enhancing
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RFDA Registration & Listing of Cosmetic Product Facilities and Products
The cosmetic facility that manufactures or processes a cosmetic product for distribution in the United States on December 29, 2022, must register each facility before July 1, 2024. Cosmetic facilities that first engage in the
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