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1,251 Results
Type: News
Section: Industry News > Regulatory
Pharmaceuticals
Promising future for specialty pharmacies
Taking a quick look at the market and the challenges in what at least one group says represents the fastest-growing segment of the pharmaceutical market.
April 10, 2015
Medical Device/Packaging
Fast-tracking medical devices through the FDA
Starting April 14, the new program will help manufacturers of devices for life-threatening, or irreversibly debilitating, conditions get approval faster.
April 9, 2015
Medical Device/Packaging
Is lack of standardized medical device labeling harming patients?
The FDA is studying if they should require standardized medical device labeling.
April 8, 2015
Nutraceuticals/Dietary
Verification program and new mark for dietary supplements
UL Consumer Products launches UL Verification Mark in response to growing industry need for third-party verification of marketing claims.
April 8, 2015
Medical Device/Packaging
Near record lows for medical device recalls
It's been two years since the FDA saw recall numbers this low.
April 7, 2015
Regulatory
FDA warns to not use products from North Carolina pharmacy
The alert comes after concerns over the company's ability to assure the sterility, stability and potency.
April 2, 2015
Regulatory
Was this experimental Ebola vaccine trial safe?
The early-stage clinical trial was conducted at the National Institutes of Health and the Walter Reed Army Institute of Research.
April 1, 2015
Labeling/Printing
FDA issues final guidance on the evaluation and labeling of abuse-deterrent opioids
The U.S. Food and Drug Administration on April 1, 2015 issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties.
April 1, 2015
Materials
FDA’s pharmaceutical quality focus continues to expand globally
PharmaLink 2015: With more products imported into the U.S. from more countries around the world, the focus must remain on patient safety and health outcomes.
March 30, 2015
Medical Device/Packaging
Does the FDA's system for approving medical devices work?
That was one of the question the Wall Street Journal posed to three experts, including a former FDA deputy commissioner.
March 25, 2015
Materials
Recipharm completes Korean serialization project for Abbott
Helps produce a datamatrix code, including serial number, for compliance with complex regulations.
March 23, 2015
Regulatory
Is drug counterfeiting the perfect crime?
With low legal risks and low barrier to entry, counterfeiters are becoming more sophisticated.
March 18, 2015
Pharmaceuticals
Forecast sees significant U.S. pharmaceutical market growth
The Patient Protection and Affordable Care Act, faster FDA product approvals, and millions of previously uninsured people potentially entering the patient pool expected to help drive future pharmaceutical growth.
March 17, 2015
Regulatory
Packaging company CEO slams FDA over drug labeling
Eliminating printed professional inserts would put pharmacies at risk, the CEO believes.
March 11, 2015
Regulatory
FDA requires new labeling on testosterone products
In addition manufactures must also conduct a clinical trial to address new concerns over increase risk for heart problems.
March 9, 2015
Regulatory
FDA finds problems with four sexual enhancement supplements
All four contained the same hidden ingredient, which could interact with other medications.
March 2, 2015
Regulatory
FDA warns against hidden drug in weight loss supplement
The agency found the product contained a controlled substance that was removed from the market in October 2010 for safety reasons.
March 2, 2015
Medical Device/Packaging
Planning for a new national medical device surveillance system
New report says regulators and experts have outlined a plan for medical devices, and the patients who use them.
March 2, 2015
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