Newsletter - August 23, 2018
FDA: Use Alternate Strategies to Include Data From “Interesting” Patients in Clinical Trials
The enrollment criteria for most clinical trials exclude older or pediatric patients, patients with organ disfunctions, pregnant and lactating women, and patients with multiple chronic conditions. An FDA report released this week summarizes how data from such patient populations can be collected to support inclusion of these populations on the product labels. Read More
What’s All the Fuss About Number of 483s Issued in India and China?
About 80% of all active pharmaceutical ingredients (API) and two-thirds of drug products sold in the US are manufactured in India and China that together boast of about 1000 FDA-registered manufacturing sites. Also, manufacturers based in the two countries hold more generic drug approvals than any other country, including the United States. Read More
FDA: Use Alternate Strategies to Include Data From “Interesting” Patients in Clinical Trials
The enrollment criteria for most clinical trials exclude older or pediatric patients, patients with organ disfunctions, pregnant and lactating women, and patients with multiple chronic conditions. An FDA report released this week summarizes how data from such patient populations can be collected to support inclusion of these populations on the product labels. Read More
What’s All the Fuss About Number of 483s Issued in India and China?
About 80% of all active pharmaceutical ingredients (API) and two-thirds of drug products sold in the US are manufactured in India and China that together boast of about 1000 FDA-registered manufacturing sites. Also, manufacturers based in the two countries hold more generic drug approvals than any other country, including the United States. Read More
