U.S. Food and Drug Administration sent this bulletin at 07/29/2022 04:14 PM EDT
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July 29, 2022
Dear Colleague,
As you and other public health advocates work on the front lines of the COVID-19 pandemic, we want you to know that we recognize your concerns about protecting the safety of yourselves, your families, and others you care for. The FDA’s work is critical to ensuring the health and safety of the American public at any time, but is magnified during public health emergencies.
As we address the challenges of the COVID-19 pandemic, protecting the public’s health, using science to guide our decisions, and facilitating access to critical medical products continue to be top priorities for the FDA.
FDA Provides Update on Agency Response to Monkeypox Outbreak
Today, the FDA is providing an update on its multipronged response to monkeypox in the United States, including its efforts in the areas of diagnostics, vaccines and therapeutics. The agency has also established a dedicated website to provide important information about the FDA’s ongoing regulatory activities related to monkeypox along with frequently asked questions. The FDA will provide updates as developments occur and will continue to work with federal public health partners and industry to ensure timely access to all available medical countermeasures.
Resources for Parents and Caregivers on Imported Infant Formula
The FDA has created resources for parents and caregivers to help explain some of the processes associated with, and results of, the agency’s efforts to help facilitate importing infant formula.
On May 16, 2022, FDA announced increased flexibilities for the importation of infant formula products, which have resulted in more than 520 million bottles worth of infant formula coming to the U.S.
Many of the imported products are, or will be soon, available through regular places to shop for infant formula, like major retailers, grocery stores and their online counterparts, as well as through company-specific websites.
The genes in your body’s cells play a key role in your health. Indeed, a defective gene or genes can make you sick.
Recognizing this, scientists have worked for decades on ways to modify genes or replace faulty genes with healthy ones to treat, cure, or prevent a disease or medical condition.
This research is paying off, as advancements in science and technology today are changing the way we define disease, develop drugs, and prescribe treatments.
The FDA has approved multiple gene therapy products for cancer and rare disease indications.
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.
This guidance is intended to assist sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and supplements to such applications who are planning to conduct clinical studies in neonatal populations.
This guidance provides recommendations to clinical investigators and sponsors regarding the inclusion of patients who have not received available therapy (commonly referred to as existing treatment options) for their cancer in clinical trials of drugs and biological products for the treatment of cancer in the non-curative setting (i.e., when there is no potential for cure or prolonged/near normal survival).
FDA has updated this guidance to include FDA’s compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain class I devices considered consumer health products.
The FDA and 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. 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.
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.
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 provide an overview of comparative Q3 characterization as well as IVRT and IVPT studies for topical generic drug product development and common deficiencies FDA has encountered in these studies. This webinar will highlight best practices and resources that FDA has developed and made publicly available to help generic drug applicants successfully implement efficient in vitro characterization-based BE approaches for topical generic products.
CDER SBIA is hosting this three half-days conference in collaboration with the Promoting the Quality of Medicines Plus (PQM+) program, which is funded by the U.S. Agency for International Development (USAID) and led by the United States Pharmacopeial Convention. PQM+ provides technical assistance to build in-country capacity of medical products regulatory authorities’ QA systems in low-and middle-income countries (LMICs). PQM+ also provides technical support to manufacturers of quality-assured priority medical products for tuberculosis (TB), malaria, neglected tropical diseases, other infectious diseases, and family planning and reproductive health as well as maternal, newborn, and child health.
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
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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