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March 1, 2022

Pediatric Tracking Requirements Under FDAAA

The Food and Drug Administration Amendments Act (FDAAA) requires that the FDA track and make publicly available certain pediatric information resulting from pediatric clinical trials pursuant […]
March 1, 2022

Hernia Recurrence Has Improved Only Slightly Hernia Recurrence Has Improved Only Slightly

Dr Dana Telem About one in six patients undergoing hernia repair require reoperation within 10 years, according to a new research letter published March 1 in […]
March 1, 2022

Sleep Disorder (Sedative-Hypnotic) Drug Information

Sedative-hypnotic drug products are a class of drugs used to induce and/or maintain sleep. FDA Drug Safety Communications: Prescription Insomnia Drugs (UPDATED) For prescribing information, please […]
March 1, 2022

Needle-Free Epinephrine Products Could Be Available in 2023 Needle-Free Epinephrine Products Could Be Available in 2023

Longstanding anxiety around use of epinephrine autoinjectors has prompted research into alternative delivery routes for this life-saving medication. Several companies presented posters on their needle-free epinephrine […]
March 1, 2022

FDA approves drug for adults with rare form of bone marrow disorder

Action FDA has granted accelerated approval for Vonjo (pacritinib) capsules to treat adults who have a rare form of a bone marrow disorder known as intermediate […]
March 1, 2022

Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry

Docket Number: FDA-2018-D-2777 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research Oncology Center of Excellence The purpose […]
March 1, 2022

Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry

Docket Number: FDA-2018-D-3292 Issued by: Guidance Issuing Office Oncology Center of Excellence Center for Biologics Evaluation and Research Center for Drug Evaluation and Research This guidance […]
March 1, 2022

New CAR T Cell for Multiple Myeloma Approved by FDA New CAR T Cell for Multiple Myeloma Approved by FDA

A new treatment option for patients with refractory/relapsed multiple myeloma who have already tried four or more therapies has been approved by the US Food and […]
March 1, 2022

FDA Says New Alzheimer’s Drug Should Have Limited Use. What Are the Implications?

Share on PinterestUnder a new FDA rule, an Alzheimer’s drug will be used only to treat people in the early stages of the disease. MoMo Productions/Getty […]
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