drug approval

The formal process through which drugs are tested before they are permitted to be sold. In the U.S., the process involves a series of studies on small groups of patients affected by diseases for which the drug may prove beneficial. These trials include: 1. studies of the drug's safety; 2. studies of the drug's efficacy; 3. studies of the drug's comparative efficacy relative to other agents that treat the same or similar problems.

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EvaluatePharma views lumateperone as the third-biggest potential new drug approval ahead in the back half of 2019.

5 Biggest New Drug Approvals Potentially On The Way In 2019

The US Food and Drug Administration (FDA) has granted investigational new drug approval (IND) to France-based Sensorion to proceed with SENS-401, based on preclinical data and clinical development plan, it was reported yesterday.

US FDA grants investigational new drug approval for Sensorion to proceed with SENS-401

"New chemical entities are required to go through the full drug approval process which requires demonstration of safety and efficacy," said CEO Patrick McEnany.

Catalyst Pharmaceuticals files federal lawsuit against FDA

Overall, about 70% of speakers (76 out of 112) supported drug approval, the study found.

HIDDEN CONFLICTS: Speakers at FDA advisory meetings may not disclose everything

Overall, about 70% of speakers (76 out of 112) supported drug approval. Speakers who disclosed a conflict of interest were significantly more likely to support drug approval.

Speakers at FDA advisory meetings have hidden conflicts

Roughly a decade ago, the FDA created accelerated ("fast-track") drug approval pathways to get drugs for rare, life threatening conditions to patients faster.

FDA Approvals: On a Fast-Track to Disaster

We all need a drug approval process that delivers good decisions based on adequate evidence.

Flawed approval process

Hamburg pushed to speed up the drug approval process and proposed measures to improve nutrition, like limiting trans-fats in foods and posting calorie counts on restaurant menus.

FDA commissioner Dr. Margaret Hamburg resigns

According to a representative from InterVest, a Korea-based VC firm that manages the Fund, CrystalGenomics' potential had already been recognized by the Korean government in the summer of 2012 when it became one of the 43 companies to be designated as the Korea Innovative Pharmaceutical Company (KIPC) and only 2 years later, CrystalGenomics is now on track to become the first bio venture company from Korea to obtain a new drug approval, which is unprecedented in the industry.

CrystalGenomics Receives KRW 13 Billion in Strategic Investment from the Global Pharmaceutical Industry Development Fund

There's an urgent need for innovative new drugs, especially for the treatment of "antibiotic-resistant infections and rare pediatric disease." Policymakers have already done much to speed innovation; the focus now is on pouring more money into research and speeding the drug approval process.

I want a new drug

As part of the National Multiple Sclerosis Society's annual Public Policy Conference, more than 300 MS activists went to Washington, D.C., on March 6 to urge Congress to preserve funding for MS research and drug approval.