Wednesday, February 20, 2019
The Detroit News-25 minutes ago
Warren — Pain pill scalpers roamed the parking lot at a Macomb County clinic embroiled in one of the nation's largest health care fraud cases, chugging booze,
The News Journal-12 hours ago
A federal judge has denied a Williamsburg pharmacist's request to be released from jail as she awaits sentencing on charges of unlawfully dispensing controlled
Ohio County Monitor-18 hours ago
Get full access to the Ohio County Monitor and support quality local journalism with a $5 monthly subscription, or SAVE with a longer subscription. It costs less
Dayton Daily News-18 hours ago
The Ohio Attorney General is arguing the state is owed $15.8 million from a company that manages pharmacy benefits for Ohio Bureau of Workers' ...
Yost seeking to recover nearly $16M in prescription overcharges
Tiffin Advertiser Tribune-Feb 19, 2019
Tiffin Advertiser Tribune-Feb 19, 2019
vtdigger.org-2 hours ago
... the importation of insulin from countries like Canada, where the drug comes at a ... The problem is compounded, he said, with the middlemen — the insurance ..
Mondaq News Alerts-19 hours ago
"Pharmacies and pharmacists have a legal obligation to dispense controlled substances properly, so as not to put patients' health at risk," said Assistant Attorney .
The Columbus Dispatch-19 hours ago
After nearly a year of investigating, Ohio is taking its first steps to recover money from pharmacy middlemen who do billions of dollars worth of business with state
Courier Journal-7 hours ago
FRANKFORT — A long-awaited state report appears to confirm legislators' suspicions that industry middlemen, known as pharmacy benefit managers, are ...
Lexology-1 hour ago
FDA Finalizes Compounding Rule – The FDA announced the finalized rule setting out six bulk drug substances that can be compounded and four that cannot be .
KRMG-4 hours ago
TULSA - Federal prosecutors in Tulsa say a physician will pay the government nearly $85,000 to settle allegations he was involved in a kickback scheme.
STLtoday.com-10 hours ago
ST. LOUIS • A compounding pharmacy that sued Express Scripts more than four years ago has paid nearly $367,000 in attorney's fees and costs for misconduct,
Sarasota Herald-Tribune-10 hours ago
The owners of a Sarasota compounding pharmacy will pay at least $775,000 to resolve claims that they engaged in an illegal kickback scheme. The U.S.
KTUL-12 hours ago
Shores says the settlement resulted from an investigation into health care providers who wrote prescriptions for pain creams compounded and sold by OK ...
Tulsa doctor to pay $84K after being involved in kickback scheme ...
Local Source-kjrh.com-15 hours ago
Local Source-kjrh.com-15 hours ago
Monday, February 18, 2019
Sarasota pharmacy owners agree to pay $775,000 settlement: A Sarasota pharmacy and its owners are out at least $775,000 to settle a federal lawsuit.
JD Supra (press release)-Feb 14, 2019
Dietary supplements, as defined by the Federal Food, Drug and Cosmetic Act; ... drugs;; Homeopathic drugs;; Compounded drugs;; Investigational new drug
Stocks Beat-Feb 13, 2019
These drugs, essentially, could be as much as 25 percent stronger than they ... least one Pharmakon employee to backdate batch records of compounded drug
Florida Record-13 hours ago
ATTORNEY'S OFFICE OF FLORIDA: Florida Compounding Pharmacy And Its Owners To Pay At Least $775,000 To Resolve False Claims Act Allegations.
Lexology-8 hours ago
The pharmacy exemption came into force on 1 February 2019. In many other European countries (such as Germany, France and the UK), pharmacists were
Friday, February 15, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on new policy to improve access and foster price competition for drugs that face inadequate generic competition
In too many cases, branded drugs that are no longer protected by patents or other exclusivities do not face expected competition. In fact, there are several hundred of such branded drugs that do not have any generic competition. Instances like these may keep prices high and ultimately hurt American patients.
We’ve been taking new policy steps at the FDA to support downward pressure on drug prices by helping to clear a path for more efficient generic development. In doing so, we know that various factors may influence a manufacturer’s decision to develop and market a generic drug. For example, some drugs may not attract a high level of interest if there is a limited market for them. We also know that some drugs may ...
FDA advances new efforts to promote development of safe and effective regenerative medicine products
Today, the FDA finalized two guidance documents regarding regenerative medicine therapies. Both documents were first issued in draft in November 2017 as part of a suite of guidances that comprised the FDA’s comprehensive regenerative medicine policy framework.
The first final guidance, Evaluation of Devices Used with Regenerative Medicine Advanced Therapies,which is required by the 21st Century Cures Act, clarifies how the FDA will evaluate devices used in the recovery, isolation or delivery of regenerative medicine advanced therapies (RMATs). The guidance specifies that devices intended for use with a specific RMAT may, together with the RMAT, be considered to comprise a combination product.
The second final guidance, Expedited Programs for Regenerative Medicine Therapies for Serious Conditions, describes the expedited programs that may be available to sponsors of regenerative medicine therapies for serious conditions, including the new Regenerative Medicine Advanced Therapy (RMAT) designation created by the 21st Century Cures Act, Priority Review designation andAccelerated Approval. In addition, the guidance describes the regenerative medicine therapies that may be eligible for RMAT designation.
Very High Importance!! FDA In Brief: FDA continues to advance oversight of drug compounding by finalizing a rule providing information on several bulk drug substances compounders not registered as outsourcing facilities can and cannot use
Wednesday, February 13, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D. on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs
Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission. One of the fundamental elements of overseeing the quality and safety of pharmaceuticals is having a clear understanding of the specific processes and technologies used to manufacture drugs throughout their lifecycle. This starts before a product is even approved and brought to market, with the FDA’s premarket (or preapproval) review of drug applications. This includes a careful review of information about product and manufacturing quality, as well as, in many cases, premarket inspections of a company’s intended manufacturing facility to ...
Tuesday, February 12, 2019
NewsWest9.com-16 hours ago
DALLAS — Curtis Cosby went in for what he believed was routine cataract surgery, but days after, he soon realized something had gone terribly wrong
What is a compounding pharmacy? Why, what you should know | wfaa ...
14 hours ago - Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding includes the combining of two or more drugs.