Tag Archives: fda

Inspector’s report suggests potential for vape shop quality control issues

Mary Otto

About Mary Otto

Mary Otto, a Washington, D.C.-based freelancer, is AHCJ's topic leader on oral health and the author of "Teeth: The Story of Beauty, Inequality, and the Struggle for Oral Health in America." She can be reached at mary@healthjournalism.org.

Photo: Brad Wilmot via Flickr

A recent report on the results of a series of unannounced “vape shop” visits by federal inspectors raises questions about quality-assurance in the preparation of some e-cigarette products.

Vape shops typically sell products, including electronic nicotine delivery devices and “e-liquids” solutions that are atomized by heating elements within the devices. When inhaled, the resulting vapor delivers nicotine, flavorings and other additives to the user. Continue reading

These FDA apps can be helpful for reporting and story ideas

Tara Haelle

About Tara Haelle

Tara Haelle (@TaraHaelle) is AHCJ's medical studies core topic leader, guiding journalists through the jargon-filled shorthand of science and research and enabling them to translate the evidence into accurate information.

If you are familiar with  Drugs@FDA, you know that the website allows you to quickly look up a drug by its name (brand), the active ingredient (generic), or application number. But if you frequently work on the go or need to look up something quickly while away from your computer, you now can download the FDA’s new app, Drugs@FDA Express (iOS/Apple and Android/Google), to see much of the same information.

Released in late March, the app is pretty basic, but often that’s the best kind of app. It loads quickly, isn’t overly cluttered and has simpler user-friendly interface. The opening page is straightforward. Continue reading

Skepticism is required when covering the science behind genetic tests

Joseph Burns

About Joseph Burns

Joseph Burns (@jburns18), a Massachusetts-based independent journalist, is AHCJ’s topic leader on health insurance. He welcomes questions and suggestions on insurance resources and tip sheets at joseph@healthjournalism.org.

Photo: Pia Christensen/AHCJCharles Piller, Paul Raeburn and Christopher Robertson (left to right) discussed the science of genetic testing on the first day of Health Journalism 2018.

Health insurers struggle to understand whether genetic tests give physicians actionable information about how to diagnose and treat patients’ illness. If health insurers struggle, then journalists certainly will as well. For example, see this tip sheet that Beth Daley (@BethBDaley) wrote for AHCJ when she was at the New England Center for Investigative Reporting.

Genetic testing holds immense promise, but as speakers explained during the “Science of Genetic Testing” session at Health Journalism 2018, misuse and misinterpretation of these tests have undercut that promise. Continue reading

Gene therapy development on the rise but costs remain an issue

Markian Hawryluk

About Markian Hawryluk

Markian Hawryluk (markianhawryluk) covers health and fitness issues for The (Bend, Ore.) Bulletin. He has won numerous awards for his health writing from AHCJ and the Society of Professional Journalists and won the 2009 Bruce Baer Award for Investigative Journalism. In 2012, he was named a Knight-Wallace Fellow at the University of Michigan.

After decades of unfulfilled promises and setbacks, the field of gene therapy broke through with three FDA-approved products last year, ushering in what is likely to be a rapid escalation of new treatments for some of the rarest and most debilitating diseases.

“Part of the idea of the Human Genome project was that once we had the identity of all the genes, it would be important and straight forward for us to development more therapeutic options for people with serious inherited diseases, said Katherine High, M.D., president and director of research and development for Philadelphia-based Spark Therapeutics. “But it turned out this took a little longer to do than the Human Genome project.” Continue reading

Putting a human face on new antimicrobial research

Bara Vaida

About Bara Vaida

Bara Vaida (@barav) is AHCJ's core topic leader on infectious diseases. An independent journalist, she has written extensively about health policy and infectious diseases. Her work has appeared in outlets that include the National Journal, Agence France-Presse, Bloomberg News, McClatchy News Service, MSNBC, NPR, Politico and The Washington Post.

Photo: CDC/Courtesy of Larry Stauffer, Oregon State Public Health LaboratoryA positive result of a phage test showing diminished growth (arrowhead) where a gamma phage suspension had been applied.

A desire to put a human face to antibiotic resistance led reporter Chris Dall to dig into the relatively unknown world of viral research aimed at killing superbugs.

Dall began investigating bacteriophages, which are viruses that kill bacteria, when he was assigned a story to write about a study that appeared in the scientific journal, Antimicrobial Agents and Chemotherapy in August 2017. The report dryly described a method of using viruses to save a 68-year-old man, who was dying from an antibiotic-resistant infection. Continue reading

Draft guidance signals FDA seeks to foster innovation in digital health sector

Rebecca Vesely

About Rebecca Vesely

Rebecca Vesely is AHCJ's topic leader on health information technology and a freelance writer. She has written about health, science and medicine for AFP, the Bay Area News Group, Modern Healthcare, Wired, Scientific American online and many other news outlets.

The FDA’s new guidance on digital health paves way for more tools that aim to support physicians and patients.

Expect to see a slew of new software programs and tools aimed to support clinicians and patients to make informed treatment decisions, after the Food and Drug Administration released its long-awaited draft rule last week on clinical decision support (CDS) systems. Continue reading