FDA

FDA's Flush List: Assessing the Environmental Impact

FDA's Flush List: Assessing the Environmental Impact

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Researchers attempted to quantify the environmental effects of disposing certain drugs by flushing them down the toilet, and found that this approach poses a negligible eco-toxicological risk.

Meningitis Vaccine: Precautionary Recall

Meningitis Vaccine: Precautionary Recall

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A precautionary recall of Menveo, a meningitis vaccine, was announced by GlaxoSmithKline due to a mechanical intervention.

Interchangeability Study Initiated for Adalimumab Biosimilar

Interchangeability Study Initiated for Adalimumab Biosimilar

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Boehringer Ingelheim has initiated a clinical study to investigate the interchangeability between an adalimumab biosimilar candidate and Humira.

FDA Grants Recurrent UTI Vaccine Fast Track Designation

FDA Grants Recurrent UTI Vaccine Fast Track Designation

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Sequoia Sciences announced that the FDA has granted Fast Track Designation to its investigational vaccine for recurrent urinary tract infections caused by multi-drug resistant bacteria.

Ceftin Oral Suspension to be Discontinued

Ceftin Oral Suspension to be Discontinued

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GlaxoSmithKline has made the decision to discontinue manufacturing Ceftin Oral Suspension, a cephalosporin antibacterial drug.

Aimovig Under Review for Migraine Prophylaxis

Aimovig Under Review for Migraine Prophylaxis

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The FDA has accepted for review the Biologics License Application for Aimovig for migraine prophylaxis in patients experiencing more than 4 migraine days per month.

Strategies to Curb the Opioid Epidemic: A National Academies Report

Strategies to Curb the Opioid Epidemic: A National Academies Report

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Highlights from the National Academies of Sciences, Engineering, and Medicine report titled "Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use."

FDA Policy Seeks to Increase Number of Generics on Market

FDA Policy Seeks to Increase Number of Generics on Market

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The FDA has announced a new policy to expedite reviews of generic drug applications in cases where competition is limited.

New Treatment for Opioid-Induced Constipation

New Treatment for Opioid-Induced Constipation

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Naldemedine, a recently approved agent for opioid-induced constipation, showed good safety and significantly higher responder rates than placebo in a couple of 12-week, international, randomized trials.

FDA Issues Contraindications, Warnings on Codeine, Tramadol Use

FDA Issues Contraindications, Warnings on Codeine, Tramadol Use

The FDA is restricting the use of codeine and tramadol medicines in children.

FDA Guidance on Medical Product Marketing Communication

FDA Guidance on Medical Product Marketing Communication

The FDA released guidance to establish standards for communications about products.

FDA Approves Zilretta NDA for Knee Osteoarthritis

FDA Approves Zilretta NDA for Knee Osteoarthritis

The Food and Drug Administration has accepted for review the New Drug Application for Zilretta for the treatment of patients with osteoarthritis of the knee.

FDA Recommendations For Naming of Biologics

FDA Recommendations For Naming of Biologics

The FDA has issued a final guidance document for the naming of reference biological products and biosimilars.

What the FDA Can Do to Help Bring Improved Pain Medicines to the Market

What the FDA Can Do to Help Bring Improved Pain Medicines to the Market

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Dr Katz formulated 10 recommendations for the FDA, 3 of which he detailed during his presentation.

Delays Noted In The Reporting Of Serious Patient Harms To FDA

Delays Noted In The Reporting Of Serious Patient Harms To FDA

Analysis found roughly 10 percent of cases were filed after 15-day deadline passed.

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