FDA continues clampdown on compounders

FDA continues clampdown on compounders

BioPharma Dive-8 hours ago

Compounding can play an important role in treating certain groups of patients whose needs aren't met by existing products, like those allergic to certain ...

Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings

Millions of Americans take medication daily to control their blood pressure. We recently found that some generic versions of one medication, valsartan, contain an impurity that doesn’t meet FDA’s safety standards. Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. The FDA currently has a major operation underway to investigate and address this troubling finding. This investigation is led by a dedicated task force of experts focused solely on this important work. Their mandate is to oversee the investigation and track new developments and information coming in from valsartan manufacturers. This multidisciplinary team of chemists, toxicologists, medical doctors, pharmacists, investigators, communication specialists, and analytical lab staff coordinates across the FDA, and acts on the newest available information. Continue reading...

District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs

		The U.S. District Court for the District of New Jersey entered an order of permanent injunction against S Hackett Marketing LLC doing business as Just Enhance; R Thomas Marketing LLC; Shawn Hackett, president and owner of Just Enhance; and Roger Thomas, president and founder of R Thomas Marketing LLC. The permanent injunction requires the defendants to, among other things, cease the distribution of drugs until they take specific remedial measures and comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act). Continue reading...

Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis

Over the past 17 months, we’ve set out to address the opioid crisis forcefully, using all the agency’s tools and authorities. These steps have been part of a comprehensive approach that the Secretary of Health and Human Services has outlined. Our efforts at the U.S. Food and Drug Administration are part of these broader efforts and cut across three broad areas. Continue reading...

FDA IN BRIEF: FDA launches new pilot to advance innovative clinical trial designs as part of agency’s broader program to modernize drug development and promote innovation in drugs targeted to unmet needs

Today, the U.S. Food and Drug Administration announced a new pilot program (“Complex Innovative Designs Pilot Meeting Program”) in which drug and biologic companies who participate in the pilot program will have additional opportunities to meet with agency staff to discuss the use of novel complex innovative trial designs (CID) for their clinical development programs. Complex innovative trial designs includes the use of seamless trial designs, modeling and simulations to assess trial operating characteristics, the use of biomarker enriched populations, complex adaptive designs, Bayesian models and other benefit-risk determiniations, and other novel designs. The new program is aimed at helping to solidify the science used to support these novel approaches, and promote their adoption in drug development programs where these trial constructs can advance innovation. Continue reading...

FDA Law Blog--

Facing Continuation of the Endo/Par Vasopressin Lawsuit, FDA Publishes Notice Concerning List of Drug Substances for Which there is [NOT?] a Clinical Need under Section 503B

Posted: 28 Aug 2018 08:05 AM PDT

By Karla L. Palmer —

FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products Firm recalls hundreds of water-based products for humans and pets due to microbial contamination

The Food and Drug Administration is warning consumers and pet owners not to use drug products, including homeopathic drug products, made by King Bio Inc., Asheville, N.C., and labeled as Dr. King’s, as these products may pose a safety risk to people (especially infants, children, pregnant women and those with compromised immune systems), as well as pets due to high levels of microbial contamination identified at the manufacturing site. King Bio has expanded its voluntary recall for a second time to include all water-based (aqueous) drug products marketed for human and animals. The FDA recommends that consumers stop using and dispose of these products immediately. 

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FDA takes action against 21 websites marketing unapproved opioids as part of agency’s effort to target illegal online sales

		The U.S. Food and Drug Administration today announced it has warned four more online networks, operating a total of 21 websites, illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol. The warning letters issued by the FDA to each of the networks state that they must immediately stop illegally selling these products to American consumers. Continue reading...

Texas Tightens Disclosure Rules Following Medicaid Investigation

NPR/Center for Public Integrity (August 17, 2018) Essley Whyte, Liz

California Board of Pharmacy Meeting Scheduled for September 7, 2018

September 7, 2018 Webcast

West Coast University – Classroom 372 590 North Vermont Ave. Los Angeles, CA 90004