Information Requests and Discipline Review Letters of US FDA

·         The Generic Drug User Fee Amendments of 2017 (GDUFA II) was signed into law on August 18, 2017 in order to facilitate timely access to high quality, affordable generic medicines.

 ·         As part of GDUFA II, FDA agreed to two program enhancements centered on improving communications during a review-cycle:

- Discipline Review Letters; and

- Information Requests.

 ·         The recently published draft guidance entitled Information Requests and Discipline Review Letters Under GDUFA, explains how the Agency intends to deploy these two program enhancements during the review of an original abbreviated new drug application (ANDA).

 

Discipline Review Letter (DRL)

Ø  Generally, a DRL will be issued from each discipline as it finishes its initial review of its portion of a received ANDA.

Ø  It will not represent a complete review of the entire submission and does not necessarily reflect input from all supervisory levels.

FDA approves first treatment for COVID-19

 

The U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval.

This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered under the EUA, the FDA revised the EUA for Veklury to authorize the drug’s use for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg. Clinical trials assessing the safety and efficacy of Veklury in this pediatric patient population are ongoing.