Monday, April 1, 2019

Louisiana Board of Pharmacy April 2019 Newsletter

Arizona Board of Pharmacy April 2019 Newsletter

Eastern Panhandle pharmacist ordered to pay more than $335K for ...

Herald-Mail Media-1 hour ago
MARTINSBURG, W.Va. — A former Eastern Panhandle pharmacist was ordered Monday to pay $335,670 in civil penalties for filling prescriptions in violation of ..

CBD sold in Ohio stores despite pharmacy board ruling restricting ...

The Columbus Dispatch-14 hours ago
Stores throughout Ohio continue to sell cannabidiol, commonly known as CBD, months after the state's Board of Pharmacy ruled that the cannabis extract may ..

Oklahoma pharmacy owner charged after allegedly getting over $1 ... kfor.com-6 hours ago MANGUM, Okla. –



Oklahoma pharmacy owner charged after allegedly getting over $1 ...

kfor.com-6 hours ago
MANGUM, Okla. – An Oklahoma pharmacy owner has been charged with dozens of counts related to healthcare fraud after allegedly scamming healthcare ...

Another horse fatality at Santa Anita; 23 thoroughbreds have died at track since Dec. 26

https://www.msn.com/en-us/sports/more-sports/another-horse-fatality-at-santa-anita-23-thoroughbreds-have-died-at-track-since-dec-26/ar-BBVt7oZ?ocid=spartandhp

FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards

The U.S. Food and Drug Administration today posted warning letters to four companies who produce homeopathic drug products for significant violations of current good manufacturing practice (CGMP) regulations, including a letter to King Bio Inc. of Asheville, N.C. The FDA previously warned the public about the agency’s serious concerns with the quality of drug products produced by King Bio. 

“In late 2017, the FDA proposed a comprehensive, risk-based enforcement approach to drug products labeled as homeopathic and marketed without the required FDA approval. While the agency continues to examine this approach, the homeopathic industry has continued to grow, and we need to continue to address, consistent with our current enforcement policies, situations where products labeled as 
Posted: 01 Apr 2019 01:49 AM PDT
The Food and Drug Law Institute (FDLI) is holding a conference devoted to digital health regulatory issues:  Medical Devices: FDA Regulation in the Era of Technology and Innovation. Hymn, Phelps & McNamara’s Jeffrey K. Shapiro is the Chair.  The conference will be held in South San Francisco on June 6, 2019.  The keynote address will be delivered by Bakul Patel, Associate Director of Digital Health at FDA’s Center for Devices and Radiological Health (CDRH).  The conference will examine FDA’s efforts to adapt medical device regulation to modern day digital health technology and the practical impact on firms that must interact with FDA.  Learn more (and register) here.  (Use code “CaMedDev” for a special 15% discount.)

FDA Announces Funding Opportunity to Help Define Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals

The U.S. Food and Drug Administration today announced a funding opportunity and Request for Applications (RFA) for studies that can help target and define durations of use for certain medically important antimicrobial drugs approved for use in the feed of food-producing animals. The agency also posted a list of the affected products.

From April 1 to June 1, 2019, the FDA’s Center for Veterinary Medicine (CVM) will accept research applications for the Fiscal Year (FY) 2019 program, which will fund up to $1.5 million in support of applications for studies in FY 2019, with a maximum of $250,000 provided to any individual awardee. Subject to resources and awardee performance, awardees will be eligible for an additional year of support in FY 2020 up to $250,000. The number of awards is contingent upon FDA funding availability and the number of suitable applications.

The FDA is offering funding to help generate publicly available data that sponsor(s) of affected approved animal drug applications can use to update product dosage regimens to better target when and for how long the drug may be used. Defining more targeted durations of use supports the FDA's ongoing efforts to slow the development of antimicrobial resistance by fostering the judicious use of medically important antimicrobial drugs in animals. 


NERC Conference Ponders the Human Element to Reliability

RTO Insider-7 hours ago
“What should have been four dice became one,” he said — the active failure of choosing the wrong drug compounded by the nurse's failure to perform the other