Drugs
Drager Medical has begun a Class 1 recall of its emergency transport ventilators due to a system error that may lead to a halt in ventilation therapy. Affected devices include the Oxylog 2000 plus, Oxylog 3000, and Oxylog 3000 Plus ventilators distributed between 4/2007 and 12/2015. A recall
Drugs
Astellas senior vice president Jeffrey Bloss says it’s “time to create a modernized regulatory framework that encourages the development and dissemination of accurate, data-driven information, including real-world evidence, to achieve high-quality, high-value patient care.” Writing in a sponsored opinion piece on The Hill online, Bloss
Drugs
FDA’s Office of Orphan Product Development (OOPD) received 472 requests for orphan drug designations in 2015, five more than the record-setting 467 requests in 2014. Attorney Kurt Karst (Hyman, Phelps & McNamara), writing in his firm’s FDA Law Blog, says that OOPD “designated an amazing 354 products
Drugs
Amgen is asking the Court of Appeals for the Federal Circuit to uphold a district court decision that Apotex is required to provide 180-day notice to Amgen of its intent to market a biosimilar version of Amgen’s Neulasta (pegfilgrastim). In its brief, Amgen says that “because the district
Drugs
The Justice Department says that Junaid Qadir, 33, of Karachi, Pakistan, entered a pro-forma not guilty plea in Colorado federal court to multiple charges of illegal importation and sale of misbranded and unapproved new drugs, some of which were alleged to have been counterfeit or controlled substances, and all
Drugs
FDA has lifted a partial clinical hold against Heat Biologics’ Phase 2 clinical trial evaluating HS-410 either alone or in combination with standard of care Bacillus Calmette-Guérin (BCG) for treating non-muscle invasive bladder cancer. Heat says it will now resume patient enrollment. “Our clinical timelines remain materially
Devices
Public Citizen says that a provision in the 21st Century Cures legislation that would encourage FDA to rely on articles published in peer-reviewed journals to determine the effectiveness of a medical device is a bad idea. In its second report on specific provisions of the legislation, Public Citizen says
Drugs
FDA has released a draft guidance on Cyclosporine Bioequivalence Recommendations for generic cyclosporine 0.05% emulsion/ophthalmic products. The document offers two options — an in vitro or in vivo study for demonstrating bioequivalence. The agency says that in order to qualify for the in vitro option, the test and reference-
Biologics
FDA’s Arthritis Advisory Committee has voted 21 to 3 to support the approval of Celltrion’s proposed biosimilar CT-P13 after finding it highly similar to Janssen’s Remicade (infliximab). Panel members agreed with agency reviewers’ assessment that CT-P13 was highly similar, notwithstanding minor differences in clinically inactive
Drugs
FDA has placed a full clinical hold on CTI BioPharma’s pacritinib clinical studies due to its “detrimental effect on survival.” Earlier this week, the company said a partial clinical hold was ordered on the myelofibrosis drug (see story) due to excess mortality and other adverse events in pacritinib-treated
Drugs
A 2014 FDA inspection at Ipca Laboratories’ Ratlam, Pithampur, and Piparia Silvassa facilities in India found significant violations for finished pharmaceuticals and active pharmaceutical ingredients, including “systematic data manipulation,” according to a 1/29 Warning Letter. Violations included: Ratlam Facility failing to have computerized systems with sufficient controls to prevent
Drugs
Attorney Irena Royzman (Patterson Belknap) says that the World Health Organization (W.H.O.) final proposal for a worldwide biosimilar naming convention released 1/26 is similar to the FDA proposal that has drawn industry criticism. W.H.O. would add a “biologic qualifier” (BQ) suffix consisting of four random
Drugs
The Senate Health, Education, Labor and Pensions Committee 2/9 favorably voted out seven bipartisan bills on biomedical innovation. Despite the favorable votes, there remains a divide on providing FDA and NIH with funding to implement the measures. The next HELP meeting is scheduled for 3/9, where the committee
Devices
Members of the FDA Circulatory System Devices Advisory Panel meet 2/18 to discuss and make recommendations on clinical trial, post-approval study design, and physician training for leadless cardiac pacemaker device technology. A briefing document released in advance of the session says that specifically the committee will be asked
Drugs
Four senators have introduced bipartisan legislation to add Zika to the FDA Priority Review Voucher (PRV) program that encourages development of treatments for neglected tropical diseases. The measure is sponsored by Sens. Al Franken (D-MN), Bill Nelson (D-FL), Johnny Isakson (R-GA), and Sherrod Brown (D-OH). They
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays. This guidance document discusses information to be included in premarket notifications for zonisamide or lamotrigine assays. To download this guidance, click here. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Display Devices for Diagnostic Radiology. It provides recommendations for the types of information that should be provided in premarket notification submissions (510(k)) for display devices intended for diagnostic radiology with the assigned product code PGY. This guidance, when
FDA Policy/General
Federal Register Notice: FDA is announcing Booz Allen Hamilton’s final evaluation report submitted as part of their independent assessment of the process for the review of medical device submissions. To view this notice, click here.
FDA Policy/General
Federal Register Notice: CDER is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program. The Center is inviting pharmaceutical companies interested in participating in this program to contact CDER. To view this notice, click here.
Devices
CDRH associate director for digital health Bakul Patel says the Center has taken steps to encourage interoperability of medical devices as a way to improve patient care and reduce errors. Writing in an FDA Voice blog post, Patel defines interoperability as the “rapid transfer and use of information between and
Drugs
CDER Division of Medication Error Prevention and Analysis deputy director Lubna Merchant says that a draft guidance issued last year is to help drug and biologic product sponsors develop proprietary names that don’t cause or contribute to medication errors or misbrand a drug. Writing in a From Our Perspective
Drugs
Repros Therapeutics met with FDA reviewers 2/4 to discuss a 12/2015 complete response letter on the company’s NDA for enclomiphene for treating secondary hypogonadism in overweight men wishing to restore normal testicular function. “The meeting agenda covered a broad range of topics surrounding the NDA data as