Last September, U.S. regulators faced a dilemma: whether to allow importation of drug ingredients from a Chinese factory with a history of poor quality controls, or face shortages of treatments for American cancer patients.
The US Senate passes a resolution declaring July the national anti-counterfeit awareness month.
European Union agency responsible for the protection of public and animal health through the scientific evaluation and supervision of medicines.
Wockhardt gets EIR with observations from USFDA for 3 plants
The U.S. Food and Drug Administration has become something of a bogeyman for India’s stock market.
A snapshot of exports around the world.
July 1, 2016: New Hampshire Couple Indicted On Two Counts Of Illegal Distribution Of Prescription Drugs
Ongoing investigations in Indonesia have uncovered counterfeits in 37 medical facilities across nine provinces.
Counterfeit versions of a dental adhesive have been discovered in Germany and the Netherlands.
Special agents with the Drug Investigation Division of the Tennessee Bureau of Investigation are warning about a recent dramatic increase in the prevalence of counterfeit prescription drugs, according to a recent news release.
Lax regulation and disreputable "compounding pharmacies" pose a threat to patients.
FDA Takes Action Banning Imports From 4 Indian and Chinese Firms Under GDUFA’s User Fee Provisions http://p0.vresp.com/T7IS7F
FDA Takes Action Banning Imports From 4 Indian and Chinese Firms Under GDUFA's User Fee Provisions. The FDA on Wednesday banned imports from Chinese and Indian generic drug companies because they failed to pay fees and meet identification requirements stipulated in the Generic Drug User Fee ...
The move is part of a drive to weed out supplies of substandard drugs in the market, a senior official in the health ministry told ET.
EDQM's Annual Report: 18% of the sites inspected were not GMP-compliant http://p0.vresp.com/m7tzBC
EDQM's Annual Report: 18% of the API sites inspected were not GMP-compliant. An important part of the CEP procedure by the EDQM is the inspection of the site where the APIs are being manufactured. The objective of such inspections is on the one hand to check whether the company produces ...
By Pat Anson, Editor
With much of the U.S. focused on the so-called epidemic of prescription
opioid abuse, another deadly problem is quietly taking root around the
country: illicit fentanyl being sold as counterfeit pain medication.
“It’s unreal. They’re inundated with fentanyl in the Midwest and in the
northeast,” says DEA spokesman Rusty Payne. “A lot of these fentanyl pills
are being marketed as knockoff oxy (oxycodone).”