Drugs
FDA says it has concluded that the scope of exclusivity ordered by a federal court for Eagle’s leukemia drug Bendeka extends to all applications containing the same active moiety as Bendeka, bendamustine, and bars approval of any application containing bendamustine for any exclusivity-protected indication starting on the 12/
Drugs
The CDER Office of Pharmaceutical Quality (OPQ) says that in 2018 it worked on implementing four strategic priorities: collaboration, innovation, communication, and engagement. The OPQ 2018 annual report says it improved integration of internal processes to find more efficiencies. It also held public events to encourage quality-related innovation within
Drugs
On the heels of a substantial budget boost (see story) for this fiscal year, FDA commissioner Scott Gottlieb has outlined for U.S. House of Representative appropriators significant modernization efforts underway in CDER’s Office of New Drugs (OND). Beginning in the next few months, CDER will adopt new standard
Drugs
Parexel International has hired former FDA Oncology Center of Excellence deputy director Amy McKee as regulatory consulting services vice president. McKee, who spent 11 years at FDA, will focus on building Parexel’s new cross-functional oncology initiative, according to the company. At FDA, she served as Office of Hematology
Drugs
FDA has approved Genentech’s Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) subcutaneous injection for treating patients with HER2-positive early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature) in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with
FDA Policy/General
Federal Register notice: FDA has announced a public meeting and an opportunity for public comment on “Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities.” The meeting is intended to obtain patients’ and caregivers’ perspectives on impacts of rare diseases on daily life and to assess commonalities that
FDA Policy/General
Federal Register notice: FDA is amending its regulations to reflect a change of address for CDER’s Office of Generic Drugs Document Room from Rockville, MD, to Beltsville, MD. The new address is: Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901–B Ammendale Rd.
Drugs
Lehigh Valley Technologies (LVT) has agreed to pay $4 million to settle False Claims Act allegations that it designed a scheme to avoid paying fees to FDA associated with NDAs. A Justice Department news release says the Allentown, PA, firm is a drug company that develops and commercializes certain human
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it appreciates FDA’s efforts on biomarker qualification, including through the agency’s biomarker qualification program. “The issuance of the draft guidance represents another critical step in qualification of drug development tools by providing a clear and predictable framework for sponsors engaged
Devices
Physio-Control has begun a Class 1 recall of its LifePak 15 monitor/defibrillator because the device may “lockup” (freeze) after a shock is delivered. “When this occurs, the device’s monitor display goes blank and there is no response from the keypad or the device although the device’s
Drugs
Two drug stakeholders say they support a request in a Pfizer 8/22/18 citizen petition that FDA issue guidance to ensure truthful and non-misleading communications by reference product sponsors on biosimilar safety and effectiveness, including interchangeable biologics, relative to the reference products. The Association for Accessible Medicines and
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Formal Dispute Resolution; Appeals Above the Division Level” (OMB Control Number 0910-0430). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Quality Considerations for Continuous Manufacturing.” The document describes several key quality considerations and provides recommendations for how applicants should address these considerations in various drug submissions for small molecule, solid oral drug products that are produced via a continuous
FDA Policy/General
Timothy Schell has returned to FDA to lead CVM’s the Office of Surveillance and Compliance, effective 2/17. After 14 years at CVM, Schell left the agency in 2014 to join Elanco Animal Health to lead its regulatory affairs strategies in several different areas. He earned a Master of
Biologics
CBER has issued a guidance, Providing Lot Release Protocol Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format, to assist manufacturers of biological products regulated by CDER to submit lot release protocols in electronic format. The document updates and supercedes a 2007 guidance. The agency says
Drugs
The Office of Generic Drugs (OGD) says that in 2018, the first year for GDUFA 2, it approved or tentatively approved 1,021 ANDAs and published more than 250 new or revised guidances, product-specific guidances, and manuals of policies and procedures for stakeholders. In its annual report, OGD also
FDA Policy/General
Federal Register notice: FDA has announced a 3/19-20 meeting of the National Center for Toxicological Research’s (NCTR) Science Advisory Board. On 3/19, panel members are scheduled to hear an NCTR update on scientific initiatives and accomplishments during the past year. On 3/20, representatives from CBER,
Devices
FDA says it is monitoring the impact on medical device supply issues and potential shortages arising from a seal order issued by the Illinois Environmental Protection Agency to the Sterigenics Willowbrook product sterilization facility that resulted in the facility ceasing operations. An online CDRH message says medical devices accounted for
Devices
FDA has cleared a Medtronic 510(k) for the Accurian RF ablation platform for use in radio frequency ablation of nerve tissues for treating pain. The device “combines proprietary hardware and quad core processing with advanced software for power and temperature control resulting in consistent and predictable lesion formation,” the
Drugs
Bayer says it has completed a rolling NDA submission to FDA for its investigational prostate cancer drug darolutamide. The company says the submission is based on data from a Phase 3 ARAMIS trial in men with non-metastatic castration-resistant prostate cancer. FDA has given darolutamide a fast track designation.
Drugs
FDA has issued Adamis Pharmaceuticals a Refusal to File letter on an NDA for its sublingual tadalafil product, indicated for treating erectile dysfunction. Upon a preliminary review, FDA determined that the NDA was not sufficiently complete to permit a substantive review, according to the company. The agency requested that Adamis
Drugs
A 6/11-6/14/18 FDA inspection at Proandre SL, a Barcelona, Spain, drug manufacturing facility, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 2/13 Warning Letter says specific violations were: * failing to have for each batch of drug product appropriate laboratory