Health Archive

CSOFT’s health sciences blog aims to provide a better understanding of complex diseases, and regulatory polices from conducting experiments to introducing new type of drugs into the market.

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FDA Grants 510(k) Clearance for Respinova’s Pulsehaler

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...

FDA Provides New & Revised Product-Specific Guidances

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...

Takeda’s Dengue Vaccine Begins Regulatory Submissions

Takeda’s Dengue Vaccine Begins Regulatory Submissions

Takeda's dengue vaccine candidate's filing packages has been accepted by the European Medicines Agency (EMA), which is being investigated for its prevention of dengue in individuals between the ages of 4 and 60. Takeda also submitted the vaccine for regulatory...

LetsGetChecked’s COVID-19 At-Home Test Approved by FDA

LetsGetChecked’s COVID-19 At-Home Test Approved by FDA

The U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) LetsGetChecked's COVID-19 at-home test to sell directly to consumers at retail stores as well as online. Peter Foley, CEO and Founder of LetsGetChecked stated, “While the...

Merck Granted Label Expansion by FDA for Keytruda

Merck Granted Label Expansion by FDA for Keytruda

Keytruda, Merck's checkpoint inhibitor, has been granted label expansion by the U.S. Food and Drug Administration (FDA) for first-line treatment for patients diagnosed with, regardless of PD-L1 expression, locally advanced or metastatic gastroesophageal or esophageal...

FDA Provides Smooth Pathway for COVID-19 Screening Tests

FDA Provides Smooth Pathway for COVID-19 Screening Tests

The U.S. Food and Drug Administration (FDA) is providing further guidance and a smoother path for COVID-19 screening tests, specifically for asymptomatic patients. Part of this process includes the release of a fact sheet for those interested in organizing screening...

EMA Offers Guidance on Labeling for COVID-19 Therapeutics

EMA Offers Guidance on Labeling for COVID-19 Therapeutics

The European Medicines Agency (EMA) offered guidance on labeling requirements for COVID-19 therapeutics as a follow up on their guidance from last year that offered labeling requirement flexibilities on COVID-19 vaccinations. According to the EMA, the product's...

E-Labeling for the Life Sciences Industry

E-Labeling for the Life Sciences Industry

There has been a drastic increase in regulations surrounding labeling for medical devices over the past decade. As our world shifts towards a more digital landscape, e-labeling, which is an electronic version of an Instruction for Use (IFU), has become more popular...