I just ran across this today:
Information for Consumers and Patients | Drugs - FDA.gov
A good mix of information and popular topics.
Thoughts and resources about health, drugs and prescriptions, and how they are affected by GMPs (FDA Good Manufacturing Practices) and other regulations.
I just ran across this today:
Information for Consumers and Patients | Drugs - FDA.gov
A good mix of information and popular topics.
According to the article:
"Millions of Americans receive their medications by mail but many, like Becker, find themselves forced to do so by their insurance plans or face the prospect of paying exorbitant amounts for the same drugs.
An NBC News investigation found the growth of mail-order pharmacies has caused many people to feel trapped in a system that has left them with crushed pills, damaged vials and lifesaving drugs exposed to extreme weather. ...
Interviews with more than 65 mail-order pharmacy customers across the nation revealed deep worries over how their medication is delivered — and no affordable alternatives. Many reported receiving drugs in flimsy packaging without temperature indicators, which can cost as little as a dollar per package. Others have had to plead with pharmacies to send them replacement drugs after receiving medication they thought arrived too warm or cold."
Read the full source article: Millions of Americans receive drugs by mail. But are they safe? - NBC News
"Eban has covered the pharmaceutical industry for more than 10 years. She notes that most of the generic medicines being sold in the U.S. are manufactured overseas, mostly in India and China. The U.S. Food and Drug Administration states that it holds foreign plants to the same standards as U.S. drugmakers, but Eban's new book, Bottle of Lies, challenges that notion. She writes that the FDA often announces its overseas inspections weeks in advance, which allows plants where generic drugs are made the chance to fabricate data and results."
Read more: Trump, at Biopharma Meeting, Pledges to 'Streamline' FDA, Cut Regulations but Wants Lower Prices - TheStreet:
"Biotech and drugs stocks are soaring Tuesday after President Donald Trump, meeting with CEOs of the biotech and pharma industries, promised to "streamline the FDA" and cut regulations so that new products can be brought to the market faster and cheaper."
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Read the full article: What the 21st Century Cures Act is, and who benefits from it - Business Insider:
"Sponsors of the 21st Century Cures Act call it a win-win: a fusion of funds for medical research with new rules that direct the Food and Drug Administration to approve drugs and devices with greater urgency. There's also money to help states fight the opioid epidemic, and a boost for mental health care."
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Health Canada prioritizes its work according to the risk to health that the incident may pose to Canadians. Incidents that present a potentially higher risk to health will be actioned first. Incidents of low or nominal risk will be assessed and entered into our tracking system for possible future compliance action as deemed appropriate."'via Blog this'
The Only Vote That Counts: FDA 483 Round-Up:
"Looking at the FDA isn’t much different. Lots of folks like to predict what the FDA will do, or try to glean trends from the often cryptic public statements FDA officials make at conferences or other gatherings. But the FDAs real “votes” are in the 483s they issue.
Reading through a recently-released crop of the agency’s medical device letters, it looks like the FDA is maintaing an interest in CAPA and employee training."
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ECRI Names Top 10 Health Technology Hazards for 2013 | HITECH Answers:
"What topics made the list? Here’s the rundown: