World of DTC Marketing

APRIL 12, 2021

The goal of getting a drug to market as fast as possible so they can recoup drug development costs has the potential for mistakes that could cost lives. Coupled with all this is the continued outsourcing of raw materials and other steps in drug development. We need a 21st-century approach that puts patient safety first.

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Food and Drug Administration Prescription Pharma Manufacturing 187

PM360

NOVEMBER 29, 2022

When developing content for new drug labels, life sciences companies’ regulatory teams face challenges in gathering intelligence to better understand competitive factors, market dynamics, and effective approval strategies. Food and Drug Administration (FDA) or European Medicines Agency (EMA).

Food and Drug Administration 98

Food and Drug Administration Competition Safety Pharmacology 98

Pharmaceutical Technology

APRIL 21, 2023

The US Food and Drug Administration (FDA) has pushed quizartinib’s Prescription Drug User Fee Act (PDUFA) date in newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) for the review of updates of Risk Evaluation and Mitigation Strategies (REMS) included in the application. Quizartinib had a 11.3%

Food and Drug Administration 98

Food and Drug Administration FDA Safety Prescription 98

Pharmaceutical Technology

MAY 19, 2023

The US Food and Drug Administration (FDA) has accepted Satsuma Pharmaceuticals’ 505(b)(2) new drug application (NDA) for STS101 for acute treatment of migraine, for review. The prescription drug user fee act (PDUFA) date is expected to be set as January 2024.

Food and Drug Administration 59

Food and Drug Administration FDA Prescription Food 59

Pharma Leaders

JUNE 21, 2023

The US Food and Drug Administration (FDA) has accepted bluebird bio’s Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) gene therapy and granted priority review for the product’s use in the treatment of sickle cell disease (SCD). We look forward to working with the agency on its review.”

Food and Drug Administration 52

Food and Drug Administration FDA Prescription Food 52

Pharmaceutical Technology

FEBRUARY 8, 2023

The US Food and Drug Administration (FDA) has accepted Aldeyra Therapeutics’ new drug application (NDA) for topical ocular reproxalap to treat signs and symptoms of dry eye disease. The regulator has assigned 23 November 2023 as the Prescription Drug User Fee Act (PDUFAs) date for its decision.

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Food and Drug Administration FDA Prescription Food 52

PM360

MAY 25, 2023

The new Food and Drug Administration (FDA)’s Decentralized Clinical Trial Draft Guidance issued May 1 st has started to outline guidelines for increased oversight and planning while simultaneously supporting broader DCT adoption. The guidance document is short at 19 pages, and by design not prescriptive.

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FDA Food and Drug Administration Safety Medicine 104