July 22, 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

• July 18, 2024 - Spotlight on CDER Science Examines Impact of Disease Awareness and Prescription Drug Television Communications on Consumer Conflation
• July 18, 2024 - FDA Authorizes Marketing of Vuse Alto Tobacco-Flavored E-Cigarette Pods and Accompanying Power Unit
• July 17, 2024 - FDA Rare Disease Innovation Hub to Enhance and Advance Outcomes for Patients
• July 16, 2024 - FDA, FTC Continue Joint Effort to Protect Consumers Against Companies Illegally Selling Copycat Delta-8 THC Food Products
• July 16, 2024 - FDA Roundup
• July 12, 2024 - FDA Roundup

FDA Voices 

Men’s Health is Falling Behind – Some Thoughts About Why

As I described in my previous blog, the trajectory of men’s health in the U.S. is headed in a negative direction. As we develop approaches to reversing these trends of declining life expectancy, excess chronic disease and disproportionate risk taking, it behooves us to examine the potential underlying reasons for this decline.

From Awareness to Action: Tackling the Rising Burden of Common Chronic Diseases

Since graduating from medical school in 1978, I’ve seen medicine and healthcare change in unimaginable ways for the better. However, one of the most alarming changes is the recent decline in life expectancy in our country, largely due to the cumulative impact of common chronic diseases (CCDs), combined with excessive rates of suicide, drug overdose and gun violence, and, of course, COVID-19. How can it be that our prowess in technology is not translating into better health and longevity for the American public?

Consumer Updates

Ticks and Lyme Disease: Symptoms, Treatment, and Prevention

Tick-borne diseases, such as Lyme disease, are on the rise in people and dogs. Reported cases in people in the U.S. increased from about 12,000 annually in 1995 to more than 63,000 in 2022, according to the Centers for Disease Control and Prevention. However, not all diagnosed cases are reported and the CDC believes the true number of human infections is likely closer to 476,000 per year.

The U.S. Food and Drug Administration regulates products that are used to help prevent, diagnose, and treat this complex disease.

Public Portal for Patients, Healthcare Providers, and Organizations to Report NEW Shortages

When a medication is not available, it can be helpful to make FDA's Drug Shortages staff aware. Usually when a drug is not in stock, it's a temporary, localized issue and more product is on the way. Occasionally local supply issues can be a signal of a future drug shortage. 

When FDA receives reports of new local shortages, we contact the manufacturers to confirm if their available supply will meet the national demand for the drug. If a drug is at risk of going into shortage, sometimes this advanced notice helps FDA take early action to prevent or shorten the duration of a shortage. 

To use the public portal: 

1. First check the Drug Shortages Database for current shortages to see if FDA is already aware of this shortage. Search by your product's generic name or active ingredient. 
2. If the drug is already in the Drug Shortages Database, talk with your health care provider or pharmacist for other treatment options during the shortage. FDA is actively working on resolving that shortage. 
3. If the drug is NOT in the Drug Shortages database, send a report to FDA through our new public portal.

Guidance Documents

Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma; Guidance for Industry

This guidance provides FDA’s recommendations to blood establishments for the submission of a Biologics License Application (BLA) for the manufacture of COVID-19 convalescent plasma for transfusion intended to treat patients with immunosuppressive disease or receiving immunosuppressive treatment in either the outpatient or inpatient setting. The guidance also provides FDA’s recommendations for Investigational New Drug applications (INDs) for investigational COVID-19 convalescent plasma for transfusion.

Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment | FDA

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment.” The draft guidance was prepared by the Division of Gastroenterology in the Center for Drug Evaluation and Research at FDA to help sponsors in the clinical development of drugs to treat pediatric patients with inflammatory bowel disease. The draft guidance provides FDA’s recommendations about the necessary attributes of clinical studies for drugs being developed for the treatment of pediatric ulcerative colitis or pediatric Crohn’s disease, including study population, study design, efficacy considerations, and safety assessments.

Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy | FDA

This guidance addresses the regulatory requirements for determining donor eligibility that apply to establishments that collect blood and blood components (blood establishments) for transfusion or for further manufacturing use, including Source Plasma.  In the final rule dated May 22, 2015 (Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use (donor eligibility rule)) (Ref. 1), FDA (we) amended the regulations applicable to blood establishments for determining donor eligibility and testing blood and blood components.  The revised requirements were implemented in order to assure the safety of the blood supply and to protect donor health.  The donor eligibility rule became effective on May 23, 2016.

Application User Fees for Combination Products

This document provides guidance to industry and FDA staff on application user fees for combination products as defined under 21 CFR 3.2(e). Combination products may be reviewed in a single application or in separate applications for the constituent parts, as appropriate. The guidance explains that combination products for which a single application is submitted should be assessed the applicable user fee associated with that particular type of application. The document also addresses how the Agency applies user fees for combination products when separate applications are submitted for the constituent parts. If the applicant chooses to submit two applications for a cross-labeled combination product, each would be assessed the applicable user fee for each application. In the infrequent situation when FDA determines that a single application is not appropriate and separate applications are warranted, the guidance describes how the total application fee amount might be reduced when the applicant qualifies for certain waiver provisions under the Prescription Drug User Fee Act (PDUFA) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older | FDA

This guidance provides recommendations to sponsors on the clinical development of drugs for the treatment of partial onset seizures (POS) in pediatric patients. Specifically, this guidance addresses FDA’s current thinking regarding clinical development programs that can support extrapolation of the efficacy of drugs approved for the treatment of POS in adults to pediatric patients 1 month of age and older. This guidance does not address the development of drugs to treat other types of seizures.

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

Evaluating the Negative Symptoms of Schizophrenia in Clinical Trials

August 16, 2024; 10 a.m. - 4 p.m. ET

• Discuss the optimum approach to developing drugs to treat the negative symptoms of schizophrenia.
• Disseminate important regulatory considerations for programs designed to evaluate drugs for the treatment of the negative symptoms of schizophrenia.

ADEPT-9: Public Workshop on Enhancing Diversity in Therapeutics Development for Pediatric Patients

September 6, 2024; 9 a.m. - 5 p.m. ET

The purpose is to solicit input from stakeholders on increasing the enrollment of historically underrepresented populations in pediatric clinical studies, and encouraging pediatric clinical study participation that reflects the prevalence of the other disease or condition among demographic subgroups, where appropriate, and other topics.

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.