FDA Policy/General
The Senate Health, Education, Labor and Pensions Committee has planned a 4/6 mark-up for five FDA/biomedical innovation bills. This follows a 3/9 mark-up that favorably voted out seven bipartisan bills on biomedical innovation and seven previous bills voted out 2/9 (see earlier story). The
Devices
FDA has established a Library of Quality Practices as a resource for medical device professionals seeking to identify tools that can help them develop and update their approach to quality in their device design and manufacturing. The resources were developed as part of CDRH’s Case for Quality initiative. The
FDA Policy/General
Federal Register Notice: FDA is seeking comments on collections of information associated with Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver applications. Comments should be submitted by 5/31. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on the standardized format and content requirements for the labeling of over-the-counter drug products. Comments should be submitted by 5/31. To view this notice, click here.
FDA Policy/General
Federal Register Notice: The FDA commissioner is renewing the Arthritis Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 4/5/18. To view this notice, click here.
Drugs
After 25 years at FDA, CDER associate director for policy Jane Axelrad will retire effective 4/29. In total, she has 41 years of government service when counting legal and policy positions she held at the Nuclear Regulatory Commission and the Environmental Protection Agency prior to joining the agency in
Drugs
CDER Office of Compliance (OC) director Cynthia Schnedar has resigned and Office of Manufacturing Quality director Tom Cosgrove will assume the OC director role in an acting capacity on 4/4. Schnedar’s departure comes three months after she was recused from working on substantive issues relating to compliance actions
Drugs
Radius Health has submitted an NDA for abaloparatide-SC 80 mcg, an investigational, once daily treatment for postmenopausal women with osteoporosis. The submission is supported by data from an 18-month Phase 3 study called ACTIVE, which evaluated 2,463 postmenopausal women with osteoporosis. The company says the trial met
Drugs
Public Citizen says that the number and size of federal and state settlements in criminal and civil cases against drug companies decreased significantly in 2014 and 2015. “It remains to be seen whether this decline represents a longer-term trend,” the advocacy group says in a report updating a 2012
Drugs
FDA has published a draft guidance, Labeling for Biosimilar Products, to assist applicants in developing draft labeling for submission in applications for proposed biosimilar products. The recommendations for prescription drug labeling in the document pertain only to the package insert, except for recommendations that pertain to FDA-approved patient labeling
Drugs
Cancer Moonshot Task Force executive director Greg Simon says there are very few unknown problems that are holding back cancer research. In a National Public Radio interview, he says what is important is to take action to address the barriers that are known “because the overarching goal of this initiative
Drugs
The Biosimilars Council, a division of the Generic Pharmaceutical Association, is asking the Supreme Court to hear Sandoz’ appeal of its biosimilars patent dance case against Amgen. The council’s amicus brief says that the decision by the Court of Appeals for the Federal Circuit requiring “patent dance” notification only
Drugs
The International Council on Harmonization (ICH) has reached the adoption phase (Step 4) on an Electronic Common Technical Document v4.0 Implementation Package for Modules 2 through 5. Step 4 enables each regulatory region to start the implementation process. As part of the implementation process, FDA says it is providing
Drugs
Opko Health has received an FDA complete response letter (CRL) on an NDA for Rayaldee (calcifediol) as a treatment for secondary hyperparathyroidism in patients with Stage 3 or 4 chronic kidney disease and vitamin D insufficiency. The letter cited manufacturing deficiencies at Opko’s third-party contract manufacturer found during
Drugs
The FTC has filed suit in eastern PA federal court alleging that Endo Pharmaceuticals and several other drug companies violated antitrust laws by using pay-for-delay settlements to block generic versions of Opana ER and Lidoderm. The agency says this is the first FTC case challenging an agreement not
Devices
Houston-based Mostyn Law has petitioned FDA asking that it order a recall of Boston Scientific’s surgical mesh products because they are allegedly made of defective, counterfeit material from China. The petition, filed on behalf of a West Virginia woman who suffered health problems from a Boston Scientific pelvic
Devices
FDA says it has received reports of adverse effects and has updated its recommendations involving CT scans when patients have insulin pumps, cardiac implantable electronic devices, or neurostimulators. An agency Web site says that while most patients undergo CT scans without any adverse consequences, FDA has received a small number
Devices
FDA has cleared a Medtronic 510(k) for its PillCam COLON 2 capsule for an expanded indication — detecting colon polyps in patients with evidence of gastrointestinal bleeding of lower gastrointestinal origin. The device was originally cleared to visualize the colon for evaluating polyps in patients who are at major risks
Devices
FDA has cleared an Xtant Medical Holdings 510(k) for the Xspan Laminoplasty Fixation System and its use in the lower cervical and upper thoracic spine (C3-T3). Spinal laminoplasty is a surgical procedure performed to remove pressure from the spinal cord, according to the company. “Unlike a laminectomy, where
Drugs
Republican leaders of the House Energy and Commerce Committee say that even with intensified FDA efforts to protect heparin, “serious challenges remain to significantly reduce risks for heparin from economically-motivated adulteration.” In a 3/29 letter to FDA commissioner Robert Califf, the congressmen lay out five key problems identified
Biologics
FDA says an investigational test is available for use under an IND to screen donated blood in areas with active mosquito-borne transmission of Zika virus. An agency news release says that the Roche Molecular Systems test was developed in close collaboration with FDA. In a 2/18 guidance to
Drugs
The Justice Department says Novartis has violated a Corporate Integrity Agreement it signed following the $422.5 million settlement of a 2010 case against the company over its drug promotional practices, and should now be hit with each tougher penalties. The government says the company engaged in a nationwide kickback