FDA Law Blog: Mobile Medical Applications: A Thoughtful Guidance Is Finalized:
"The final guidance is similar to the draft guidance – but with improved clarity. Hence, it has expanded from 29 to 43 pages. Most of the additional pages are appendices with examples and other supplementary information. This guidance is sensible and well written."
Follow this link to the Mobile Medical Applications - FDA Guidance for Industry and Food and Drug Administration Staff (PDF)
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Friday, September 27, 2013
Friday, September 20, 2013
FDA Prohibits Drug Importation from Ranbaxy’s Plant in Mohali, India
"The U.S. Food and Drug Administration today issued an import alert under which U.S. officials may detain at the U.S. border drug products manufactured at Ranbaxy Laboratories, Ltd.’s facility in Mohali, India. The firm will remain on the import alert until the company complies with U.S. drug manufacturing requirements, known as current good manufacturing practices (CGMP)."
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Tuesday, September 10, 2013
New Joint Commission Video Offers Advice on Medical Care at Home
New Joint Commission Video Offers Advice on Medical Care at Home:
"Video characters Nurse Clare, Home Care Aide Jesse and Home Medical Equipment Specialist Boyd help Hector in his home with his IV, oxygen tank and daily living needs while his wife Reyna watches and helps. "Speak Up: At Home" emphasizes that patients and their families or friends should ask questions in order to be sure they receive the care necessary to get better."
Follow this link to the video, Speak Up: At Home
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The Exemptee Institute - for prospective CDPH HMDR Exemptees
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Follow this link to the video, Speak Up: At Home
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FDA Panel Backs CT Colonography
"An FDA advisory panel generally backed greater use of CT colonography in screening asymptomatic patients for colon cancer but did question certain aspects of the test."
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Monday, September 9, 2013
Did FDA Just Announce A Major Reorganization? - Forbes
"In order for FDA to best adapt to the ongoing rapid changes in the regulatory environment, driven by scientific innovation, globalization, the increasing complexity of regulated products, new legal authorities and additional user fee programs, the Commissioner has formed a Program Alignment Group (PAG). Comprised of senior Agency leaders, the PAG is charged with identifying and developing plans to modify FDA’s functions, processes, and possibly its structure in order to address these matters and best achieve mission-critical Agency objectives."
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Saturday, September 7, 2013
MedlinePlus - Free Health Information from the NLM
MedlinePlus - Health Information from the National Library of Medicine
"MedlinePlus is the National Institutes of Health's Web site for patients and their families and friends. Produced by the National Library of Medicine, it brings you information about diseases, conditions, and wellness issues in language you can understand. MedlinePlus offers reliable, up-to-date health information, anytime, anywhere, for free."
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Last-mile thefts grow dramatically this year - FiercePharma
Last-mile thefts grow dramatically this year - FiercePharma Manufacturing:
"According to FreightWatch, there have been 29 last-mile courier thefts so far this year, the majority in the Detroit, MI, area including the armed robbery of a drug-delivery vehicle in January. That compares to 12 in all of last year. Often these kinds of thefts involve violence, the company explained. FreightWatch recommends that last-mile delivery drivers try to park in secured areas."
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New - FDAzilla's FDA Inspections Database
Inspection and 483 data sliced and diced in a very interesting way. Check it out!
Start with the first link below to get oriented, then dive right in to the data via the second link below.
FDA Inspections Database is Now Available | FDAzilla Blog:
"We are proud to unveil the newest edition to the FDAzilla website – the FDA inspection database. You can search for company name, or you can drill down to the month, and then to the day, to see inspection details."
Follow this link to The FDAzilla FDA Inspection Dashboard and Database
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Start with the first link below to get oriented, then dive right in to the data via the second link below.
FDA Inspections Database is Now Available | FDAzilla Blog:
"We are proud to unveil the newest edition to the FDAzilla website – the FDA inspection database. You can search for company name, or you can drill down to the month, and then to the day, to see inspection details."
Follow this link to The FDAzilla FDA Inspection Dashboard and Database
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Monday, September 2, 2013
Who is Molly? Dangerous drug gaining popularity with new name
Updated September 2, 2023
The original link broke.
You can still read about the same topic here:
--- the original post follows below ---
"The deaths of two young adults and the hospitalization of four others this weekend following a massive electronic music festival in New York City — which was subsequently shut down by city officials — has reignited fears over the club drug MDMA, nicknamed “Molly,” which is the suspected cause of the deaths."
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3D-Printed Medical Devices Spark FDA Evaluation | LiveScience
"The FDA currently treats 3D-printed devices the same way it treats conventionally made medical devices, an FDA spokeswoman said.
"We evaluate all devices, including any that utilize 3D printing technology, for safety and effectiveness, and appropriate benefit and risk determination, regardless of the manufacturing technologies used," spokeswoman Susan Laine told LiveScience in an email. She added, "In some cases, we may require manufacturers to provide us with additional data, based on the complexity of the device." "
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Sunday, September 1, 2013
FDA - Salmonella Spice, both Scary and Deadly | Marler Blog
“Salmonella is a widespread problem with respect to imported spices,” Michael Taylor, deputy F.D.A. commissioner for food, said in an interview. “We have decided that spices are one of the significant issues we need to be addressing right now.”
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