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FDA Outlines IND Pilot to Speed Early Clinical Trials, Counter Overseas Competition

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FDA outlines its intention to overhaul the early-stage clinical development process through a planned Expedited IND Pilot, arguing...

Antimicrobial Animal Drug Finalized Safety Guidance

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FDA issues a finalized guidance on evaluating the safety of antimicrobial animal drugs based on their role in human medicine.

Quantitative Medicine Innovation Network RFI

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FDA seeks information from a variety of regulatory partners that will help it establish and implement a Quantitative Medicine Inno...

FDA, Tonix Align on Lyme Disease Prevention Phase 2 Study

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FDA and Tonix Pharmaceuticals align on the protocol for an adaptive Phase 2 study of the companys TNX-4800 to prevent Lyme disease...

Inspection Flags Sterility and Quality Control Concerns at Zydus Lifesciences

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An FDA inspection cites multiple manufacturing and quality system deficiencies at a Zydus Lifesciences Limited sterile manufacturi...

FDA Approves Takedas Orzeyful for Narcolepsy Type 1

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FDA approves Takedas Orzeyful as the first drug to treat all symptoms of narcolepsy type 1 in adults.

Fresenius Recalls Morphine Injection Syringe Lot Due to Labeling Mix-Up

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Fresenius Kabi recalls one lot of Simplist (morphine sulfate injection USP) 2 mg/1 mL prefilled syringes after discovering a label...

Senators Press FDA for Details on Addressing Chemotherapy Shortages

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Two senior U.S. senators seek answers from FDA about its plans to address ongoing shortages of several critical chemotherapy drugs...

Multiple Violations in Brunner Hygiene Unapproved New Drugs

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FDA warns Germanys Thomas Brunner Hygiene about CGMP and other violations in its production of unapproved and misbranded antipersp...

Jazz to Remove Zepzelca Second-Line Indication

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Jazz Pharma says it will seek FDA approval to remove Zepzelcas (lurbinectedin) second-line metastatic small cell lung cancer indi...