Updates Consumer Updates Want to Quit Smoking? FDA-Approved and FDA-Cleared Cessation Products Can Help  How to Choose a Smoking Cessation Product That's Right for You Smoking cessation products approved or cleared by the FDA are shown to help people quit smoking and can even double your chance of quitting successfully.
Are you or a loved one among those American adults who smoke cigarettes and want to quit? Whether this is your first attempt to quit smoking, or you've already tried several times, know that there are FDA-approved and FDA-cleared products that can assist you on your journey to becoming smoke-free.
If you're considering using a smoking cessation product and are under age 18, speak to a doctor before using these products. ICYMI! Infant Formula Supply  In the coming weeks and months, infant formula will become more and more available as efforts by the FDA and government partners to help increase supply continue to show results. As part of the efforts, imported infant formula that's been reviewed by the FDA is showing up on store shelves and on the websites of formula companies and major retailers. Because these products are new to the U.S. market, and therefore new to you, you may have questions about them. It is important to talk with your child's health care provider for recommendations on changing feeding practices, and the appropriate formulas to substitute, as you consider your options. Guidance Documents Evaluation of Therapeutic Equivalence The draft guidance explains the criteria FDA uses to evaluate the therapeutic equivalence (TE) of drug products and what the TE codes indicate. The guidance explains how FDA evaluates drug products for, and determines TE for, multi-source drug products to be listed in the Approved Drug Products With Therapeutic Equivalence Evaluations publication (the Orange Book). The guidance provides background on the fundamentals of TE and utilizes a question and answer format to provide more information on the therapeutic equivalence evaluation of approved drug products and assignment of TE codes in the Orange Book. Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--"Dose Banding" This guidance is intended to assist applicants in incorporating dose banding information into the drug labeling provided in a new drug application (NDA) submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a biologics license application (BLA) submitted under the Public Health Service Act (PHS Act), or a supplement to one of these approved applications when an applicant proposes to develop ready-to-use containers with a range of different strengths and seeks to incorporate dose banding information into the prescribing information of the proposed drug product based on dosing information of a previously approved drug product that is based on weight or body surface area (BSA). Webinars and Virtual Workshops Using Methods from PFDD Guidance 1 and Guidance 2 as Tools for Including Patient Experience Data in Clinical Trials: Lessons Learned about Data Collection and Analysis July 25, 2022; 11:00 AM - 1:00 PM ET Speakers and participants will discuss a range of issues data collection and analysis, focusing on lessons learned and on areas identified as particularly challenging for stakeholders. You may find a link to the referenced guidance documents here: PFDD Methodologic Guidance Documents Conversations on Cancer: Clinical Trial Site Selection: Fact vs Fiction July 27, 2022; 2:00 PM - 3:30 PM ET  The FDA Oncology Center of Excellence (OCE) Conversations on Cancer public panel discussion series event will address clinical trial site selection in the context of declining U.S. patient enrollment, geo-political turmoil, and our commitment to equity and diversity in clinical trials. Collaborating on Culture in the New Era of Smarter Food Safety August 3, 2022; 12:15 PM - 1:15 PM ET The FDA Stop Foodborne Illness, a non-profit public health organization, are collaborating on a webinar series that explores food safety culture, one of the core elements in FDA's New Era of Smarter Food Safety initiative. The fourth webinar, called "What More Do You Want to Know About Food Safety Culture?," will be broadcast live from the International Association for Food Protection 2022 Annual Meeting on August 3, 2022, at 12:15 p.m. ET. Speakers and attendees will engage in a question-and-answer session on an array of food safety culture topics. Registration is available for both in-person and virtual attendance. Endpoint Considerations to Facilitate Drug Development for Niemann-Pick Type C (NPC): Key Themes and Future Directions from the January 2022 Public Workshop August 4, 2022; 3:00 PM - 4:00 PM ET Niemann-Pick Type C (NPC) is a rare genetic disease that results in progressive neurological symptoms and organ dysfunction. NPC is caused by variants in either the NPC1 or NPC2 gene, resulting in impaired intracellular transport of cholesterol and other lipids. Individuals with NPC have significant unmet treatment needs. Currently, there are no approved therapies in the United States for treatment of NPC. In order to advance NPC drug development, it is important that stakeholders work together and identify strategies to support ongoing and future NPC clinical trials. Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use August 10, 2022; 1:00 PM - 2:30 PM ET On April 13, 2022, FDA published a draft guidance for industry titled Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use. This draft guidance is intended to assist Abbreviated New Drug Application (ANDA) applicants that reference a reference listed drug (RLD) intended for parenteral, ophthalmic, or otic use but are seeking approval of a drug that is qualitatively (Q1) different or quantitatively (Q2) different from the RLD with respect to a pH adjuster(s). This webinar will take a deeper look at the draft guidance, expound on the Agency's recommendations to ANDA applicants regarding the submission and content of such a waiver request, and answer questions submitted to the Federal Register Notice. 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. Did someone forward you this email? Sign up below! | 
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