Drugs
FDA has published a guidance on Safety Considerations for Product Design to Minimize Medication Errors that provides a set of principles for using a systems approach to minimize errors relating to product and container closure designs for all prescription and nonprescription drugs and biologic products. The guidance also provides examples
Devices
FDA has approved an Abiomed PMA for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps to provide treatment of ongoing cardiogenic shock. “In this setting, the Impella heart pumps stabilize the patient's hemodynamics, unload the left ventricle, perfuse the end organs and
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information “Administrative Detention and Banned Medical Devices — 21 CFR 800.55(g)(1) and (g)(2), 800.55(k), 895.21(d), and 895.22,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork
FDA Policy/General
Federal Register Notice: FDA is publishing a list of information collections that have been approved by the Office of Management and Budget. These are: Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act; Foreign Supplier Verification Programs for Importers of Food for Humans
FDA Policy/General
BIOLOGICS Guidance on Biosimilar Product Labeling Federal Register Notice: FDA is making available a draft guidance for industry entitled Labeling for Biosimilar Products. It is intended to assist applicants in developing draft prescription drug labeling for proposed biosimilar products and pertains only to the prescribing information (commonly referred to as
Drugs
FDA is requiring changes to labeled recommendations on metformin-containing medicines for diabetes to expand the drug’s use in certain patients with reduced kidney function. The current labeling strongly recommends against metformin’s use in some patients whose kidneys do not work normally. The agency says it was asked
Drugs
FDA has granted orphan drug designation to Anavex Life Sciences Corp. for its drug candidate Anavex 3-71 for treating frontotemporal dementia (FTD), described as a syndrome associated with progressive shrinking of the frontal and temporal anterior lobes of the brain, causing a decline in language skills and/or behavioral
FDA Policy/General
CVM has begun an approval rescission action against Phibro Animal Health’s carbadox and its use in treating swine because the drug may leave trace amounts of a carcinogenic residue. The Center’s move comes after it recently reexamined the drug’s safety profile and conducted a preliminary risk characterization
Drugs
FDA has created its first Combination Products Policy Council, a senior-level, agency-wide forum for discussing, resolving, and implementing product and policy issues. “Because of the multiple FDA organizations involved, this council will have decisional authority on issues relating to combination products, cross-labeled products, and medical product classification,
FDA Policy/General
Federal Register Notice: FDA seeks comments on extending Office of Management and Budget approval on the existing reporting requirements related to submitting information electronically to the Center for Veterinary Medicine using the FDA Electronic Submissions Gateway. Comments should be submitted by 6/7. To view this notice, click here.
Drugs
The European Medicines Agency (EMA) has started a review involving approved drugs that relied on studies that were conducted at Alkem Laboratories Ltds in Taloja, India. The regulator says its action is the result of a good clinical practice inspection of this site which raised concerns regarding study data used
Drugs
FDA’s Gastrointestinal Drug Advisory Committee has unanimously (17 to 0) voted to recommend approval for an Intercept Pharmaceuticals NDA for obeticholic acid (OCA) for treating primary biliary cirrhosis (PBC) in combination with ursodeoxycholic acid in adults with an inadequate response to ursodeoxycholic acid or as monotherapy in patients unable
Drugs
Is FDA looking for some wiggle room to skirt its obligation under current law to approve generic opioids in the face of unprecedented public alarm about the current abuse epidemic? Addressing the recent Rx Opioid and Drug Abuse Summit in Atlanta, FDA commissioner Robert Califf acknowledged calls for the agency
Drugs
Washington Legal Foundation (WLF) has filed an amicus brief calling on the U.S. Supreme Court to review and overturn a 6/2016 decision by the U.S. Court of Appeals for the Third Circuit that “requires exacting antitrust scrutiny for virtually any agreement between a brand-name drug company
Devices
Industry stakeholders are voicing many concerns about the FDA draft guidance on public notification of emerging postmarket medical device signals. The most comprehensive critique was submitted by the 510(k) Coalition, which “recognizes that FDA is attempting to embark on a major multi-year effort to set up systems to
Drugs
FDA has placed a clinical hold on the CARDIO-TTR study being developed by GlaxoSmithKline to evaluate Ionis Pharmaceuticals’ Ionis-TTRRX in patients with TTR (transthyreitin) amyloid cardiomyopathy. Ionis says that the hold is in place while Glaxo provides answers to FDA questions about the Phase 3 study protocol stemming
Drugs
After recent First Amendment losses, FDA has moved away from its theory of using speech by companies as evidence they may be distributing a drug for an unapproved use, according to Washington Legal Foundation chief counsel Richard Samp. Speaking at an American University College of Law seminar (video link) on
Drugs
Par Pharmaceuticals is asking FDA not to approve any ANDA for a potassium chloride oral solution drug product for use in certain pediatric patients if the proposed product contains alcohol as one of its components. The company’s 3/22 petition specifically asks that the agency: refrain from approving any
Drugs
An American College of Physicians (ACP) position paper recommends forcing drug companies to disclose their actual product and research-and-development costs and submit to price negotiation among ways to reduce the highest national spending on drugs in the advanced world. The U.S. is the only country in the
Devices
FDA is allowing the marketing of Advanced Surgical Concepts’ PneumoLiner, the first tissue containment system for use with certain laparoscopic morcellators to isolate uterine tissue that is not suspected to cause cancer. An agency statement says that although the device is an effective tissue containment system, FDA is requiring its
Devices
The Department of Homeland Security says that independent researchers in collaboration with CareFusion have identified numerous third-party software vulnerabilities in end-of-life versions of the company’s Pyxis SupplyStation system. Because the affected software versions are at end-of-life, the notice says, a patch will not be
Drugs
Pew senior director for health programs Allan Coukell says that the Promise for Antibiotics and Therapeutics for Health (PATH) act is needed to help speed development of antibiotics for limited populations of patients with serious and life-threatening bacterial infections that are resistant to current treatments. Writing online in Health