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FDA Launches DSCSA Small Dispenser Assessment

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FDA calls on small drug dispensers with no more than 25 employees to complete an assessment so the agency can evaluate the dispens...

Reps. Want FDA to Address Estrogen Patch Shortages

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Eight House Democrats ask FDA acting commissioner Kyle Diamantas what the agency is doing and can do to ease a growing shortage of...

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...

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...