How you can be prepared

While FDA and other agencies work hard every day to help prepare the nation for potential threats, everyone can be involved in disaster readiness.

During September—National Preparedness Month—learn what you can do now, including precautions for storing water and ensuring the safety of food and medical supplies for your family and pets during and after heavy rain, possible flooding and power outages.

Preparedness information from FDA

Links from our partners

HHS hurricane response updates, including Harvey and Irma
Hurricane safety tips from FEMA, and information on Harvey response and recoveryand Irma preparedness and response
Prepare for disasters and emergencies, from USA.gov, including what comes after Harvey and five tips to prepare for Hurricane Irma

Webinar for public health preparedness stakeholders

Extending Expiration Dates of Stockpiled Doxycycline: Overview of FDA Guidance

September 20, 2017, 1:00 - 2:00 p.m. ET

CDC’s Division of Strategic National Stockpile and FDA will host a webinar for an overview of FDA’s April 2017 draft guidance Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles (PDF, 226 KB).

Panelists from FDA will discuss drug product expiry date extensions, background for issuing the draft guidance, specific doxycycline products for which the guidance applies and recommended protocol for testing, and the process for requesting and receiving an authorized extension from FDA.

The webinar is open to all federal, state, and local government public health and emergency response stakeholders, non-governmental organizations, and laboratory representatives who have an interest in the process for extending the shelf life of stockpiled doxycycline for anthrax preparedness.

How to register

Register for this webinar via CDC TRAIN. Participants must have a CDC TRAIN account, which is available via http://cdc.train.org. To search and register for this webinar, enter the course ID number: 1072608. Please direct questions to snsquestions@cdc.gov.

Join FDA and CDC for an overview of FDA’s draft guidance Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles

Events

September 13, 2017: Public workshop - Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices (Silver Spring, MD and webcast) - in-person registration is full, but a webcast will be available
September 13, 2017: Public workshop - A Framework for Regulatory Use of Real-World Evidence (Washington, DC) - Register by September 12, 2017.
September 14, 2017: FDA Grand Rounds - Developing a Mechanistic Model-Based Approach to Assess Cardiac Safety of New Drugs (webcast), presented by David Strauss, MD, PhD, 12:00 - 1:00 p.m. - CE credit available
September 18-19, 2017: Public workshop - Advancing the Development of Pediatric Therapeutics (ADEPT): Application of “Big Data” to Pediatric Safety Studies (Silver Spring, MD and webcast)
September 18-19, 2017: Strategies for Effective Biological Detection Systems: A Workshop (Washington, DC), hosted by the National Academies of Sciences, Engineering & Medicine - the workshop will explore alternative effective systems that would meet requirements for the Department of Homeland Security’s BioWatch Program as a biological detection system for aerosolized agents - register
September 18-20, 2017: Global Summit on Regulatory Science (Brasilia, Brazil) - an international conference for discussion of innovative technologies and partnerships to enhance translation of basic science into regulatory applications within the global context
NEW! September 20, 2017: Extending Expiration Dates of Stockpiled Doxycycline: Overview of FDA Guidance Webcast (more info above)
NEW! September 27-28, 2017: FDA Small Business Regulatory Education for Industry (REdI): Fall Conference (Rockville, MD and webcast)

Information for industry

Draft guidance - Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies (REMS) Document Using Structured Product Labeling (PDF, 76 KB) (September 1, 2017)
Guidance - Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (PDF, 492 KB) - FDA will host a webinar for industry interested in learning more about this final guidance document on October 10, 2017. (August 31, 2017)
Draft guidance - Identifying Trading Partners Under the Drug Supply Chain Security Act (PDF, 181 KB) - comment by October 20, 2017 (Federal Register notice) (August 21, 2017)
FDA issued a Small Entity Compliance Guide to help small businesses comply with the Final Rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (or Intentional Adulteration Rule), mandated by FSMA. Please visit FDA.gov/food/fooddefense for more information about food defense and the FSMA IA Rule. (August 25, 2017)

In case you missed it

FDA is accepting applications for a new Entrepreneurs in Residence program in our digital health group. Apply by September 29, 2017.
FDA approved a new antibacterial drug, Vabomere, for adults with complicated urinary tract infections, including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria. Vabomere was designated as a qualified infectious disease product (QIDP). - more about QIDP - also see BARDA adds new antibiotic to treat drug-resistant bacterial infections in order to protect the American public (August 29, 2017)
FDA approves first U.S. treatment for Chagas disease - FDA granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. (August 29, 2017)
FDA acts to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients - Vaccinia Virus Vaccine (Live) (a vaccine that is reserved only for people at high risk for smallpox, such as some members of the military) seized after being used inappropriately in vulnerable cancer patients(August 28, 2017)
Strengthening EU-US cooperation in medicine inspections - New commitment allows FDA to share full inspection reports with European Commission and EMA(August 23, 2017)