Updates
ICYMI!
Transcripts and Recordings Available for Listening Sessions on FDA’s Proposed Tobacco Product Standards
FDA’s Center for Tobacco Products (CTP) recently proposed two product standards: one that would prohibit menthol as a characterizing flavor in cigarettes and another that would prohibit characterizing flavors (other than tobacco) in all cigars. On June 13 and June 15, 2022, FDA held virtual listening sessions to give the public an opportunity to verbally provide open public comment on the proposed product standards.
FDA Recognizes National Immunization Awareness Month
National Immunization Awareness Month provides us an opportunity to think about how far the development and advancement of immunization science has come, and its impact on public health. The FDA plays a key role in immunization by evaluating vaccines for safety and effectiveness before they are made available to the public.
Generic Drugs Undergo Rigorous FDA Review
Maybe you’ve had this experience: You go to fill a prescription, and the pharmacist mentions there is a generic available. You’ve noticed generic drugs often cost less and wonder: How can I be sure they are as safe and effective as brand name drugs?
Applying the rigorous standards set out by law, the FDA ensures that generic drugs are as safe and effective as the brand name drug products they copy. Today, about 9 in 10 prescriptions filled in the U.S. are for generic drugs.
Guidance Documents
Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies
This final guidance is intended to help applicants (or “you”) design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a modified risk tobacco product application (MRTPA), a premarket tobacco product application (PMTA), or a substantial equivalence report (SE Report).
Charging for Investigational Drugs Under an IND: Questions and Answers
This guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulations on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use (21 CFR 312.8), which went into effect on October 13, 2009.
Webinars and Virtual Workshops
Drug Development Considerations for the Prevention of Healthcare-Associated Infections
August 30, 2022; 8:30 AM - 5:00 PM ET
The Centers for Disease Control and Prevention (CDC) and FDA are co-sponsoring this public virtual workshop.
Discussions are planned around the following topics/areas:
- The current state of development of pathogen-directed products used to prevent healthcare-associated infections
- Evidence supporting decolonization and pathogen reduction (in colonized patients) as a strategy to prevent infection and transmission of antimicrobial-resistant healthcare-associated pathogens
- Antimicrobial resistance threats as potential targets for decolonization and pathogen reduction
- Challenges and potential approaches to drug development and registration of products for the prevention of healthcare-associated infections
Compounding Quality Center of Excellence Annual Conference
September 6 - 8, 2022
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The conference will highlight how stakeholders can protect patients from unsafe, ineffective, and poor-quality compounded drugs while preserving access to compounded drugs for patients who have a medical need for them.
The conference will feature subject matter expert presentations, interactive sessions, and roundtable conversations. Stakeholders in the compounding community will share their perspectives. Attendees will be able to engage with FDA, learn about emerging trends, and gain quality compounding insights.
2022 Scientific Computing Days
September 7 - 8, 2022; - ET
The FDA Scientific Computing Board is a group of scientists and IT specialists at FDA who advocate for scientific computing needs, and requirements to advance FDA’s scientific and regulatory mission. The 10th annual Scientific Computing Days symposium is a conference promoting the latest advances in scientific computing technologies.
Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act
September 8, 2022; 9:30 AM - 3:30 PM ET
In 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) amended the FD&C Act to require that each person (including repackers and labelers) who registers with FDA under section 510 of the FD&C Act with regard to a human or animal drug must report annually to FDA the amount of each listed drug that was manufactured, prepared, propagated, compounded, or processed by such person for commercial distribution.
In this webinar, FDA will provide an overview of the drug amount reporting program, including discussions of how FDA uses the drug amount report data and who reports and how (with examples and demonstrations).
FDA Grand Rounds: Polio Vaccines: Past, Present and the Future
September 8, 2022; 12:00 PM - 1:00 PM ET
FDA regulatory science played a leading role in the evaluation and the development of state-of-the-art quality control methods for the new generation of polio vaccines. The presentation will discuss the evolution of vaccines against poliomyelitis driven by the change in disease epidemiology, socio-economic circumstances, and advances in biotechnology.
Successfully Navigating the USPTO and FDA
September 8, 2022; 1:00 PM - 5:00 PM ET
FDA, the U.S. Patent and Trademark Office (USPTO), the Silicon Valley PTO, and Biocom California will hold a free virtual meeting in which participants can hear about the intricacies that biotech and medtech independent inventors and startups face when seeking regulatory approval from the FDA and securing intellectual property rights from the USPTO.
Public Webinar - Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments – Draft Guidance
September 9, 2022; 12:00 PM - 3:00 PM ET
The FDA is hosting a webinar for industry, patient groups, and other interested stakeholders to discuss and answer questions about the draft guidance: Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments.
About Us
The Stakeholder Engagement Staff resides within the Office of the Commissioner and falls under the Office of External Affairs. We aim to build stronger relationships with health professional organizations, consumer groups, trade associations, patient advocacy organizations, think tanks/academia, and other stakeholders, in order to better inform our policy making process, identify policy hurdles or stakeholder misconceptions, and create strategic collaborations.
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