Dear Colleague,
FDA’s Stakeholders Engagement Team works to provide you with up-to-date information that helps to further our commitment in advancing public health and well-being. A few notable items were issued this week, including:
Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new policies aimed at preventing youth access to, and appeal of, flavored tobacco products, including e-cigarettes and cigars- FDA is proposing to end current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products such as electronic cigarettes (other than tobacco-, mint-, and menthol-flavored products), and prioritize enforcement of such products offered for sale in ways that pose a greater risk for minors to access these tobacco products. (March 13, 2019)
The FDA's Oncology Center of Excellence (OCE) in cooperation with Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) announced the availability of multiple guidances, to include:
FDA’s Stakeholders Engagement Team works to provide you with up-to-date information that helps to further our commitment in advancing public health and well-being. A few notable items were issued this week, including:
Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing new policies aimed at preventing youth access to, and appeal of, flavored tobacco products, including e-cigarettes and cigars- FDA is proposing to end current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products such as electronic cigarettes (other than tobacco-, mint-, and menthol-flavored products), and prioritize enforcement of such products offered for sale in ways that pose a greater risk for minors to access these tobacco products. (March 13, 2019)
The FDA's Oncology Center of Excellence (OCE) in cooperation with Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) announced the availability of multiple guidances, to include:
- Cancer Clinical Trial Eligibility Criteria: Patients with Human Immunodeficiency Virus, Hepatitis B Virus, or Hepatitis C Virus Infections; Draft Guidance for Industry
- Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients; Draft Guidance for Industry
- Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies; Draft Guidance for Industry
- Cancer Clinical Trial Eligibility Criteria: Brain Metastases; Draft Guidance for Industry
- Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials; Final Guidance for Industry
The FDA published draft guidance for industry - A Risk-Based Approach to Monitoring of Clinical Investigations -- Questions and Answers (March - 2019)
The FDA approved a new generic of Diovan (valsartan) - Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. (March 12, 2019)
The FDA approved a new generic of Diovan (valsartan) - Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. (March 12, 2019)
If you have any questions please feel free to contact our office FDAStakeholderEngagementTeam@
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