Drugs
CDER director of professional affairs and stakeholder engagement John Whyte is leaving at the end of August to become chief medical officer at WebMD. In an e-mail to Center staff, director Janet Woodcock says that since Whyte joined CDER in 2013, he has worked with her to increase the
Drugs
FDA says it has approved Novartis’ Kisqali (ribociclib) in combination with an aromatase inhibitor for treating pre/perimenopausal or postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. Kisqali also was approved in combination with fulvestrant for treating postmenopausal women with HR-
Drugs
FDA has issued an International Conference on Harmonization (ICH) guidance, E17 General Principles for Planning and Design of Multiregional Clinical Trials, to describe general principles for the planning and design of multiregional clinical trials with the aim of increasing the acceptability of such trials in global regulatory submissions. The document
Drugs
FDA has issued a draft question-and-answer guidance to provide its current thinking on the requirements for submission of field alert reports (FARs) by NDA and ANDA applicants. The draft also outlines the agency’s recommendations for FAR submissions to help increase their consistency and relevancy. And it addresses
Drugs
Washington Legal Foundation (WLF) challenges the FDA position that its proposed product jurisdiction rule is intended to merely clarify existing regulations and update them to reflect agency practices and procedures. “WLF respectfully submits that the proposed rule accomplishes neither objective,” its comment letter says. “Nor has FDA taken this opportunity
Drugs
FDA has approved a Janssen Pharmaceutical NDA for Symtuza (darunavir), a single-tablet regimen for treating human immunodeficiency virus type 1 in treatment-naïve and certain virologically suppressed adults. Approval was based on data from two 48-week, non-inferiority, pivotal Phase 3 studies that assessed the safety and efficacy
Drugs
FDA has published a guidance, Use of Electronic Health Record Data in Clinical Investigations, to assist sponsors, clinical investigators, contract research organizations, institutional review boards, and other interested parties in using electronic health record (EHR) data in FDA-regulated clinical investigations. The document defines electronic health systems for its purposes
Drugs
FDA has issued a guidance, Labeling for Biosimilar Products, to help applicants develop draft labeling for proposed biosimilar products for submission in a 351(k) application. The document says its recommendations for prescription drug labeling pertain only to the prescribing information (package insert) except for certain recommendations pertaining to FDA-
Drugs
CDER Office of Generic Drugs (OGD) director Kathleen Uhl has announced her intention to retire 2/2019. Uhl joined FDA in 1998 as a CDER medical officer in clinical pharmacology. In 2010, she was appointed deputy director of CDER’s Office of Medical Policy, and became acting director of OGD
Drugs
A 12/12-12/18/17 FDA inspection at bB BioChem Laboratories, Santa Ana, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 7/3 Warning Letter says the inspection also revealed that the firm manufactures unapproved new drug products. Specific violations noted were:
Drugs
Cook Group says it believes that an FDA proposed rule on product jurisdiction will assist the agency to achieve its public health mission. Its comment letter requests clarifications or changes to the proposal’s language on clarifying the scope of the regulations, streamlining and clarifying the appeals process, aligning the
Drugs
FDA has published a draft guidance, Innovative Approaches for Non-Prescription Drug Products, with two new approaches sponsors can use to demonstrate safety and effectiveness in cases where the drug facts labeling alone is not sufficient to ensure that a drug product can be used safely and effectively in a
Drugs
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution — 21 CFR Part 207” (OMB Control Number 0910-0045). To view the notice, click here.
Drugs
Recent studies by the Tufts Center for the Study of Drug Development find that protocol design practices increase clinical costs and inefficiencies, place a growing burden on internal and external staff performance, and affect study volunteer recruitment and retention rates. The July/August Impact Report published by the center (purchase
Drugs
A 7/27-8/4/17 FDA inspection at Baxter’s Claris Injectables, Ahmedabad, India, found significant violations of current good manufacturing practice (GCMP) regulations for finished pharmaceuticals. A 7/5 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or
FDA Policy/General
FDA has published a report summarizing the major points explored with stakeholders at a 4/16 public workshop on “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The report says the workshop “provided an opportunity for representatives from academia, industry, healthcare delivery, government, and patient advocacy groups to discuss a
Drugs
FDA has cleared a Vallum Corp. 510(k) to market a polyetheretherketone (PEEK) spinal interbody fusion device with a PEEKplus nanotextured surface created by the company’s proprietary Accelerated Neutral Atom Beam technology. “Nano-scale concavities of 20-50 nanometers are created by the impact of argon atoms across the
Drugs
Doctors and patients appear to have misconceptions about the strength of evidence to support FDA breakthrough therapy designation, according to a study by Yale School of Medicine researchers. “The analysis revealed that therapies granted this designation often reach the point of regulatory approval with trial data that lacks randomization and
Drugs
FDA says several companies have recalled their valsartan-containing drug products, which are used to treat high blood pressure and heart failure, due to an impurity detected in the active ingredient. The impurity, N-nitrosodimethylamine (NDMA), is classified as a probable human carcinogen based on results from laboratory tests. The
Drugs
A federal court has sentenced Kristjan Thorkelson (Manitoba, Canada) and several associated Canadian companies to forfeit $29 million in illegal proceeds and to pay a $5 million fine for shipping unapproved drugs to U.S. healthcare providers. “In 2010, it came to the attention of the FDA that Canada Drugs
Drugs
Federal Register notice: FDA has made available a draft guidance entitled “Long Term Follow-Up After Administration of Human Gene Therapy Products.” The document provides recommendations on the design of long term follow-up observational studies for the collection of data on delayed adverse events following gene therapy administration. To
Drugs
Federal Register notice: FDA has made available a draft guidance entitled “Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up.” The document provides recommendations regarding the testing for replication competent retrovirus (RCR) during the manufacture of such products, and