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 “The issuance of the draft guidance represents another critical step in qualification of drug development tools by providing a clear and predictable framework for sponsors engaged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Federal Register notice: FDA has made available a draft guidance entitled “Quality Considerations for Continuous Manufacturing.”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
Drugs
A 2/8-3/1/18 FDA inspection at the Pure Source drug manufacturing facility in Doral, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 2/20 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of
Drugs
On the heels of a critical CBS 60 Minutes report that claimed FDA ignited the current opioid crisis, commissioner Scott Gottlieb says the agency will require opioid manufacturers to conduct long-term studies to evaluate whether the drugs maintain their effectiveness with chronic use. “This is a critical question,” he
FDA Policy/General
Federal Register notice: FDA has issued a proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. The proposed rule describes the conditions under which OTC sunscreen monograph products would be generally recognized as safe and effective and not misbranded. It is
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations.” The document revises and replaces part of a 2002 FDA guidance on “Food- Effect Bioavailability and Fed Bioequivalence Studies.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Bioavailability Studies Submitted in NDAs or INDs — General Considerations.” The document revises and replaces an FDA 3/2014 draft guidance on “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations.’’ To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has reopened the comment period for an 11/20/2018 notice entitled “Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments.” Electronic or written comments should be submitted by 4/29. To view the notice, click here.
Drugs
FDA has released the FDA-483 with two observations it issued following a 12/3-12/14/18 inspection at Aurobindo Pharma Unit 4, Hyderabad, Telangana, India. Specific inspection observations were: * failing to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; and