Their e-mail addresses Are and , respectively. 2 In virtually all developed countries and many undeveloped ones as well, regulatory authorities provide public oversight of the safety and efficacy of many medical products and foods. In the United States, such oversight is conducted by the Food and Drug Administration (FDA), which regulates drugs,...

Recent approval of the anti-interleukin (IL)-6 receptor antibody tocilizumab by US Food and Drug Administration (FDA) for slowing rate decline in pulmonary function adult patients with systemic sclerosis-associated interstitial lung disease is a welcome step towards better treatment outcomes sclerosis. Systemic has emerged as one major causes death very high burden unmet need. Tocilizumab secon...

US public health experts are to meet this week decide how use the Pfizer BioNTech vaccine in adolescents after Food and Drug Administration (FDA) granted it emergency authorisation (EUA) for children aged 12-15.1 The vaccine, like Moderna’s, already has EUA administration people over age of 16. Both Moderna Johnson & Johnson, which make other two vaccines approved US, testing their children. ...

The Food and Drug Administration (FDA) publishes the Food Code which provides guidance on food safety, sanitation and fair dealing that can be uniformly adopted by jurisdictions for regulating the retail segment of the food industry. The model Food Code is the cumulative result of the efforts and recommendations of many contributing individuals, agencies, and organizations. Section 3-301.11 of ...

The Food and Drug Administration (FDA) approves drugs for sale in the United States based on its determination that the clinical benefits of a drug outweigh its potential health risks. To make this decision, FDA reviews supporting data collected from several thousand patients during the drug’s development. Once a drug is approved for marketing and used by potentially hundreds of thousands of pa...

Physiologically based pharmacokinetic (PBPK) modeling can be used to predict drug pharmacokinetics in virtual populations using models that integrate understanding of physiological systems. PBPK models have been widely utilized for predicting pharmacokinetics in clinically untested scenarios during drug applications and regulatory reviews in recent years. Here, we provide a comprehensive review...

On June 23, 2005, the U.S. Food and Drug Administration (“FDA”) formally approved the heart failure drug BiDil to treat heart failure in “selfidentified black patients.” The drug itself is not actually new; it is merely a combination of two generic drugs that have been used to treat heart failure for over a decade. BiDil's newness derives primarily from its public presentation as the world's fi...

Oncology nurses and pharmacists often are given the responsibility of developing or updating institutional policies to manage vesicant chemotherapy extravasations. Antidote and treatment recommendations of vesicant chemotherapy manufacturers, antidotes and treatments approved by the U.S. Food and Drug Administration (FDA), and guidelines and recommendations made by professional oncology organiz...

Droperidol has been an efficacious, inexpensive butyrophenone used since the early 1970s to prevent or treat postoperative nausea and vomiting. Because of reports of sudden cardiac death in patients receiving droperidol, the US Food and Drug Administration (FDA) recently placed significant restrictions on its administration. These restrictions have essentially removed droperidol from use. Halop...