fda

FDA Taps Social Media to Identify and Assess Emerging Drug Abuse Threats

FDA Taps Social Media to Identify and Assess Emerging Drug Abuse Threats

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The FDA continues to battle the nation's opioid problem even as it looks to detect and prevent the next threat.

FDA Clears Smartphone-Enabled Urinalysis Kit for Home Use

FDA Clears Smartphone-Enabled Urinalysis Kit for Home Use

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The Dip.io kit works in tandem with existing smartphone cameras and a dedicated app.

The FDA Has the Authority to Explain Drug Application Rejections or Approvals. They Should Use It.

The FDA Has the Authority to Explain Drug Application Rejections or Approvals. They Should Use It.

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The FDA has the ability within its governing laws to reveal to the public the reasons for its decisions to reject or approve drugs.

FDA Outlines Plan for Increasing Nonprescription Drug Availability

FDA Outlines Plan for Increasing Nonprescription Drug Availability

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The draft guidance, Innovative Approaches for Nonprescription Drug Products, applies to drugs under the New Drug Application (NDA) process and "is intended to extend that NDA pathway to include therapeutic indications that have not, historically, been available for use without a prescription," said Gottlieb in a press statement.

FDA: Scammers Sending Fake Warning Letters to Consumers

FDA: Scammers Sending Fake Warning Letters to Consumers

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"Consumers who aren't involved in manufacturing or distributing FDA regulated products should be on alert that if you get an FDA warning letter, it's probably fake, and probably a scam," said Gottlieb.

FDA Strengthens Warnings for Fluoroquinolone Antibiotics

FDA Strengthens Warnings for Fluoroquinolone Antibiotics

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The labeling changes are based on a review of postmarketing adverse event reports found in the FDA Adverse Event Reporting System (FAERS) database and published medical literature.

FDA Announces New Drug Shortages Task Force

FDA Announces New Drug Shortages Task Force

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Gottlieb said "The charge to this new task force is to look for holistic solutions to addressing the underlying causes for these [drug] shortages."

FDA: Freeze-Dried Plasma Product Approved for Medical Emergencies in Combat

FDA: Freeze-Dried Plasma Product Approved for Medical Emergencies in Combat

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French FDP has been approved by the FDA for use in military personnel in medical emergencies.

First-in-Class Inhibitor Designated Orphan Drug for Spinal Muscular Atrophy

First-in-Class Inhibitor Designated Orphan Drug for Spinal Muscular Atrophy

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By inhibiting the activation of myostatin, SRK-015 may promote a clinically meaningful increase in muscle mass and strength.

FDA Approves Avycaz for Hospital-Acquired, Ventilator-Associated Pneumonia

FDA Approves Avycaz for Hospital-Acquired, Ventilator-Associated Pneumonia

The approval of Avycaz comes as new treatment strategies to fight bacterial pneumonia are needed.

FDA Grants Orphan Drug Designation to Intranasal Acromegaly Treatment

FDA Grants Orphan Drug Designation to Intranasal Acromegaly Treatment

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DP1038 uses patented intranasal absorption technology to offer a non-injectable treatment option.

FDA: New Drug Application for Oral Drug Candidate for Major Depressive Disorder

FDA: New Drug Application for Oral Drug Candidate for Major Depressive Disorder

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ALKS 5461 (buprenorphine/samidorphan) is an oral drug candidate for the adjunct treatment of major depressive disorder.

Drugs Receiving "Fast Track" Status Associated With Increased Safety Label Changes

Drugs Receiving "Fast Track" Status Associated With Increased Safety Label Changes

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A recent study examined whether expedited drug approvals have different rates of safety-related label changes compared with drugs approved through standard pathways.

FDA Permits Marketing of First Mobile App for Substance Use Disorder Treatment

FDA Permits Marketing of First Mobile App for Substance Use Disorder Treatment

The FDA has permitted marketing of the first mobile app designed to help treat substance use disorders, including alcohol, cocaine, marijuana, and stimulant medications, but not opioids.

Would Device-Specific ICD-9 Codes Shed Light on Safety?

Would Device-Specific ICD-9 Codes Shed Light on Safety?

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The current post-approval process also does not provide the FDA with a picture of how often a device is used, but having device-specific ICD codes would change that.

FDA Approves Mavyret for Treatment of Hepatitis C

FDA Approves Mavyret for Treatment of Hepatitis C

Mavyret has been approved by the FDA to treat adults with certain types of chronic hepatitis C virus.

FDA Reviewing Potential First US Gene Therapy

FDA Reviewing Potential First US Gene Therapy

Tisagenlecleucel could be a one-time treatment for children and young adults with advanced leukemia.

Endari Approved by FDA to Treat Sickle Cell Disease

Endari Approved by FDA to Treat Sickle Cell Disease

The FDA has approved the first treatment for patients with sickle cell disease in almost 20 years.

FDA Aims to Increase Number of Generic Drugs on the Market

FDA Aims to Increase Number of Generic Drugs on the Market

The agency will now give priority reviews to new generic drugs until there are at least 3 available.

First Generic Version of Truvada Approved by FDA

First Generic Version of Truvada Approved by FDA

The generic version has been approved for treatment of HIV-1, in combination with other antiretroviral agents or for PrEP.

Radicava Approved to Treat Amyotrophic Lateral Sclerosis

Radicava Approved to Treat Amyotrophic Lateral Sclerosis

Radicava, given intravenously, slows physical decline in patients with ALS.

Companies Selling Fraudulent Cancer Treatments, FDA Warns

Companies Selling Fraudulent Cancer Treatments, FDA Warns

The unapproved products are often advertised as 'natural' and labeled as supplements.

First Drug to Treat Tardive Dyskinesia Approved by FDA

First Drug to Treat Tardive Dyskinesia Approved by FDA

Ingrezza capsules were approved for treatment of adults with tardive dyskinesia.

Lack of Negative Clinical Trial Data Concerning for Major Health Organizations

Lack of Negative Clinical Trial Data Concerning for Major Health Organizations

Health organizations, such as the WHO, FDA, and NIH have raised ethical challenges about the way clinical trial data is reported.

FDA Approves Various Direct-to-Consumer Genetic Risk Tests

FDA Approves Various Direct-to-Consumer Genetic Risk Tests

Saliva analysis can indicate a higher risk of Parkinson's disease, among others, the agency says.

New Drug Approved by FDA to Treat Various Female Cancers

New Drug Approved by FDA to Treat Various Female Cancers

The PARP inhibitor may help fight tumors affecting the ovaries, fallopian tubes or peritoneum.

FDA Approves 'Bavencio' for Merkel Cell Carcinoma Treatment

FDA Approves 'Bavencio' for Merkel Cell Carcinoma Treatment

This drug targets the PD-1/PD-L1 pathway and is the first sanctioned treatment in the United States.

FDA Approves Latest Add-on Drug 'Xadago' for Parkinson's Disease

FDA Approves Latest Add-on Drug 'Xadago' for Parkinson's Disease

This medication aims to help prevent 'off' episodes among users of levodopa/carbidopa.

FDA Approves Noctiva to Treat Nocturnal Polyuria

FDA Approves Noctiva to Treat Nocturnal Polyuria

This drug is designed to increase the absorption of water through the kidneys and decreasing urine production.

FDA Approves Xermelo for Carcinoid Syndrome Diarrhea

FDA Approves Xermelo for Carcinoid Syndrome Diarrhea

Oral tablets are to be used in combination with somatostatin analog therapy.

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