The United States Food and Drug Administration (FDA) has issued its weekly regulatory update for stakeholders.  You can read the FDA regulatory update for stakeholders below.

April 5, 2024 Dear Colleague, While the FDA continues to focus on protecting the public’s health, using science to guide our decisions, and facilitating access to critical medical products, we also recognize the work of our public health partners. As public health advocates, we know that your work to better our country is invaluable. Your partnership, knowledge and engagement in the public health space are appreciated.

Updates April 3, 2024 - FDA Approves New Antibiotic for Three Different Uses April 3, 2024 - The Office of Pharmaceutical Quality (OPQ) Issues Annual Report for 2023 April 2, 2024 - FDA Roundup April 2, 2024 - FDA Resumes Posting Regulatory Science Policy Memos on Premarket Review Process April 2, 2024 - HHS Releases White Paper Focused on Preventing Drug Shortages April 1, 2024 - Remarks by FDA Commissioner Robert Califf at the Rx and Illicit Drug Summit March 29, 2024 - FDA Roundup Spotlight! It’s National Minority Health Month and this year’s theme is “Be the Source for Better Health.” We invite everyone to be the source for clinical trial information. Share our clinical trial resources, available in Spanish and other languages: https://www.fda.gov/.../minority.../clinical-trial-diversity   Consumer Updates Colorectal Cancer: What You Should Know About Screening The evidence is clear - screening for colorectal cancer may save your life. Today, more and more people are choosing colorectal cancer screening. As a result, there is a steady decline in the number of older people getting and dying from colorectal cancer. Lower rates of smoking among Americans have also contributed to the decline in the past several years. Read More   Is Food Safe if it Has Chemicals? You may have seen news or online content about chemicals in our foods. Perhaps you’re wondering, is a food safe to eat if it contains chemicals? All our food — like everything in the world — is made up of chemicals. The presence of a chemical alone isn’t what determines whether a food is safe to eat.  Read More   Know Which Medication Is Right for Your Seasonal Allergies Seasonal allergic rhinitis, the medical term for seasonal allergies and hay fever, can also trigger or worsen asthma and lead to other health problems, such as sinus infections (sinusitis) and ear infections. The U.S. Food and Drug Administration regulates several medications that offer allergy relief. Read More   Guidance Documents Data Integrity for In Vivo Bioavailability and Bioequivalence Studies The purpose of this guidance is to provide recommendations to applicants and testing site management on achieving and maintaining data integrity for the clinical and bioanalytical portions of bioavailability (BA) and bioequivalence (BE) studies submitted in support of investigational new drug applications (INDs), new drug applications (NDAs), and abbreviated new drug applications (ANDAs), and the bioanalytical portion of clinical pharmacologic studies supporting CDER-regulated biologic license applications (BLAs) as well as amendments and supplements to these applications.  Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements This guidance expands upon and replaces the recommendations related to Master Files in the 2016 revised draft guidance (Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues). This approach of separating the 2016 revised draft guidance into discrete sections for ease of use is responsive to comments received from stakeholders.  Draft Guidance for Industry: New Dietary Ingredient Notifications and Related Issues This draft guidance expands upon and replaces the recommendations related to Master Files for new dietary ingredient notifications (NDINs) in the 2016 revised draft guidance. For more information, see Constituent Update: FDA Issues Draft Guidance on New Dietary Ingredient Notification Master Files for Dietary Supplements. Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Guidance for Industry This guidance provides instructions for the electronic submission of expedited individual case safety reports (ICSRs) from investigational new drug (IND)-exempt bioavailability (BA)/bioequivalence (BE) studies conducted to support abbreviated new drug applications (ANDAs) to FDA Adverse Event Reporting System (FAERS).  Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry FDA is announcing the availability of a final guidance for industry entitled “Providing Regulatory Submissions in Electronic Format: IND Safety Reports.” This guidance finalizes the draft guidance of the same name published on October 30, 2019 (84 FR 58158), and describes the electronic format sponsors will be required to use when they electronically submit IND safety reports to CDER and CBER for serious and unexpected suspected adverse reactions, as required under 21 CFR 312.32(c)(1)(i). View all Official FDA Guidance Documents and other Regulatory Guidance You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period. Webinars and Virtual Workshops Webinar - Draft Guidance: Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act April 30, 2024; 1 - 2 p.m. ET This draft guidance proposes updated recommendations to industry on cybersecurity considerations for cyber devices and for documentation in device premarket submissions. The Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, in its current form, remains the Agency's current thinking on this topic until this draft guidance is finalized, at which time the finalized version of Section II.                                              Registration is not required. FDA/CRCG Workshop: Considerations and Potential Regulatory Applications for a Model Master File May 2 - 3, 2024 Day 1: Thu, May 2, 2024; 8:30 a.m. - 5:30 p.m. ET Day 2: Fri, May 3, 2024; 8:30 a.m. - 3:50 p.m. ET The purpose of this workshop is to engage stakeholders among model developers, industry, and FDA in a discussion on the concept, scope, and regulatory application of a Model Master File (MMF).  Register Here   View Upcoming FDA Meetings, Conferences and Workshops Public meetings involving the FDA: Upcoming events, past meetings, meeting materials, and transcripts 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. For more information, please contact us at: FDAStakeholderEngagement@fda.hhs.gov.