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FDA Panel Votes on Drug/Device Combo to Treat Pain in Medically Supervised Setting

FDA Panel Votes on Drug/Device Combo to Treat Pain in Medically Supervised Setting

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The FDA is not bound by the Committee's recommendation but takes it into consideration when making its decision.

FDA Panel Votes on Prucalopride for Chronic Idiopathic Constipation

FDA Panel Votes on Prucalopride for Chronic Idiopathic Constipation

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The panel's decision was made based on data from from five Phase 3 studies and one Phase 4 trial which evaluated the safety and efficacy of prucalopride in patients with chronic constipation.

Treatment for Alagille Syndrome Granted Orphan Drug Designation

Treatment for Alagille Syndrome Granted Orphan Drug Designation

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Alagille syndrome affects approximately 1 in 70,000 newborns.

Talzenna Approved for Germline BRCA-Mutated, HER2-Negative Breast Cancer

Talzenna Approved for Germline BRCA-Mutated, HER2-Negative Breast Cancer

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Talzenna, a poly (ADP-ribose) polymerase (PARP) inhibitor, was evaluated in EMBRACA, an open-label trial that randomized patients with gBRCAm HER2-negative locally advanced or metastatic breast cancer to receive talazoparib 1mg or physician's choice of chemotherapy.

Liletta Now Approved for Pregnancy Prevention for Up to 5 Years

Liletta Now Approved for Pregnancy Prevention for Up to 5 Years

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The expanded approval was supposed by safety and efficacy data from the Phase 3 ACCESS IUS trial in women receiving Liletta.

FDA Announces Draft Guidance for Consumer OTC Access to Previously Prescription Drugs

FDA Announces Draft Guidance for Consumer OTC Access to Previously Prescription Drugs

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The US Food and Drug Association has issued a draft guidance for helping prescription medications gain approval for nonprescription status.

FDA Issues Safety Communication Regarding Pen Needle Use

FDA Issues Safety Communication Regarding Pen Needle Use

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Standard pen needles have an outer cover and removable inner needle cover, while safety pen needles have an outer cover and a fixed inner needle shield that is not removed before an injection.

Researchers Recommend Reclassification of Psilocybin

Researchers Recommend Reclassification of Psilocybin

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Currently, psilocybin, a serotonin receptor agonist, is classified as a Schedule I agent as it has not been approved by the Food and Drug Administration (FDA) for any therapeutic use.

FDA: Final Guidance on Heparin-Containing Devices, Combo Products

FDA: Final Guidance on Heparin-Containing Devices, Combo Products

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The intent of the document is to help reduce heparin product overdose errors caused by misinterpretation of the drug strength displayed in the labeling.

FDA Finds Another Carcinogen in Certain Valsartan Heart Medications

FDA Finds Another Carcinogen in Certain Valsartan Heart Medications

The US Food and Drug Administration warns that it has found a second impurity in three lots of Torrent Pharmaceuticals' valsartan drug products.

FDA Outlines Plan for New Analgesic Guidance to Combat Opioid Crisis

FDA Outlines Plan for New Analgesic Guidance to Combat Opioid Crisis

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The new plan will break out the current guidance into 4 separate guidances.

Study Finds Clinical Trials for Newer, Breakthrough Therapies Lacking

Study Finds Clinical Trials for Newer, Breakthrough Therapies Lacking

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More than half of the new approvals of Breakthrough Therapy drugs were based on a single pivotal trial.

FDA Seeks to Standardize Regulation of Mobile Medical Apps

FDA Seeks to Standardize Regulation of Mobile Medical Apps

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Appropriate and standardized regulation of mobile medical applications may enable faster adoption and integration of these technology platforms in the health care environment

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.

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