Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.
FDA Announces Closer to Zero Plan to Reduce Toxic Elements from Baby Food
The U.S. Food and Drug Administration (FDA) announced today an actionable plan, called Closer to Zero, to reduce the exposure of toxic elements in foods commonly consumed by babies and young children. While FDA's testing results have shown that there is no immediate...
Donisi De Novo Granted FDA Clearance for Contact-Free Multiparameter Measurement System
The U.S. Food and Drug Administration (FDA) has granted Donisi De Novo clearance for its contact-free multiparameter measurement system. The innovative system is backed by 26 patents and consists of a combination of artificial intelligence (AI), algorithms, and...
Eli Lilly and Incyte’s Atopic Dermatitis Drug Receives Extended Supplemental NDA Review
Eli Lilly and Incyte's atopic dermatitis drug received extended supplemental New Drug Application (NDA) review by the U.S. Food and Drug Administration (FDA) for baricitinib, a drug therapy intended for patients with moderate-to-severe conditions. The extension came...
FDA Grants 510(k) Clearance for Respinova’s Pulsehaler
The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for Respinova to market their device that clears secretions for patients with respiratory issues by facilitating the opening of airways. The device, called Pulsehaler, is the first to use patented...
Passage Bio’s Treatment for Krabbe Disease is Granted Orphan Designation by EMA
The European Commission has granted Orphan Designation for PBKR03, a treatment from Passage Bio to treat Krabbe disease. Krabbe disease is a rare lysosomal storage disorder that currently does not have any approved disease-modifying treatments. The approval comes...
European Commission Plans for Revision of Pharmaceutical Legislation
The European Commission released a roadmap for its planned revision of pharmaceutical legislation for next year. With the adoption of the new strategy, which is "intended to make the European pharmaceutical system patient-centered, future-proof and crisis-resistant"...
LATAM Series: Brazil’s Medical Device Regulatory Pathway
Latin America (LATAM) is a diverse region, with over 650 million people spread across 20 different countries, each with their own culture and unique history. For medical device companies, LATAM is a promising market, with its current value estimated to be $11 billion...
FDA Approves Two New Treatments for High Blood Pressure and Cancer
The U.S. Food and Drug Administration (FDA) approved of two treatments to treat high blood pressure (pulmonary hypertension) and cancer (multiple myeloma). United Therapeutics won approval for Tyvaso (treprostinil) Inhalation Solution, its pulmonary hypertension...
FDA Grants Breakthrough Device Designation for Premia Spine’s TOPS™ Spinal Arthroplasty System
The U.S. Food and Drug Administration (FDA) granted Premia Spine's TOPS™ Spinal Arthroplasty System Breakthrough Device Designation to treat patients diagnosed with spinal stenosis and spondylolisthesis. The approval marks the first ever joint replacement system for...
FDA Provides New & Revised Product-Specific Guidances
The U.S. Food and Drug Administration (FDA) has issued 22 new and 14 revised product-specific guidances (PSGs) for generic drug development. The guidances provide further clarity to the FDA's expectations in regards to clinical studies demonstrating bioequivalence...
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