FDA published on Wednesday a new batch of product-specific guidances (PSGs), providing recommendations for developing generic drugs and generating the evidence needed to support Abbreviated New Drug Application (ANDA) approval.
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The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention and treatment claims as part of our ongoing efforts to protect public health during this pandemic. As a result of these activities, the agency is beginning to see unauthorized fraudulent test kits that are being marketed to test for COVID-19 in the home.
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The U.S. Food and Drug Administration issued a draft guidance Friday outlining the goals and implementation of a new voluntary conformity assessment initiative, the Accreditation Scheme for Conformity Assessment (ASCA) Pilot, designed to promote consistency and predictability in the premarket review process for medical devices, encourage effective use of FDA resources, and enhance regulatory efficiency, while also enhancing confidence in medical device testing.
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Beximco Pharmaceuticals Limited will buy from Novartis’ Sandoz a portfolio of eight Abbreviated New Drug Applications (ANDAs) in the US
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Announcing the approval of Teva’s Sabril generic tablets, FDA Commissioner, Scott Gottlieb said that prioritizing the approval of generic drugs to compete with medicines that face little or no competition is the Agency’s key part of efforts to support access and reduce drug costs to patients.
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Novartis has secured its crizanlizumab (SEG101) Breakthrough Therapy designation US Food and Drug Administration (FDA), for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD).
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MatriSys Bioscience is waiting to meet with the US FDA to complete preparations for its company-sponsored Phase 2 trial of its anti-atopic dermatitis topical drug candidate, MSB-01, it said Wednesday.
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PledPharma has filed an application for an Orphan Drug Designation (ODD) to the US FDA for the its drug candidate which should reduce liver injury by paracetamol overdose, Aladote.
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The US Food & Drug Administration (FDA) has granted Fast Track designation to Nordic Nanovector’s Betalutin (177Lu-lilotomab satetraxetan) for the treatment of
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The U.S. Food and Drug Administration (FDA) has accepted Bayer’s partner’s Loxo Oncology’s New Drug Application (NDA), and granted Priority
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