Drugs
FDA has posted a final guidance on “Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements.” The document clarifies the agency’s requirements and addresses circumstances under which FDA intends to not take enforcement action in such matters. The guidance recommends that the established name be placed directly
Drugs
Janssen Research & Development has submitted a supplemental NDA for two new Xarelto (rivaroxaban) vascular indications: reducing the risk of major cardiovascular (CV) events such as CV death, heart attack or stroke in patients with chronic coronary or peripheral artery disease (CAD/PAD), and for reducing the risk of acute
Devices
Early next year, FDA says it will publish a draft guidance outlining a voluntary, alternative pathway for demonstrating substantial equivalence to meet 510(k) criteria for certain devices. “This pathway will allow more flexibility to use more modern criteria as the reference standard, and permit comparisons to standards that more
Drugs
FDA has approved Sanofi-Aventis’ Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged three years and older with Type 1 diabetes mellitus and adults with Type 2 diabetes mellitus. FDA says that Admelog is the first
Drugs
CDER’s Office of Testing and Research is conducting research to better understand 3D or additive manufacturing’s use in making drug products. “3D printing can offer a tantalizing step toward changing the manufacturing processes to offer personalized medicines,” a new blog post says. “For example, we are working to
Devices
FDA has approved an Intersect ENT PMA for the Sinuva (mometasone furoate) Sinus Implant, a new targeted approach to treating recurrent nasal polyp disease in patients who have had previous ethmoid sinus surgery. Inserted during a routine physician office visit, Sinuva expands into the sinus cavity and delivers an anti-
Drugs
Workshop on Software Precertification Program Federal Register notice: FDA announces a 1/30-31/2018 public workshop entitled “Fostering Digital Health Innovation: Developing the Software Precertification Program.” 12/08/2017 Comments Sought on Oncology Center of Excellence Functions Federal Register notice: FDA announces a 3/15/2018 public meeting entitled
Drugs
DEVICES FDA has approved Foundation Medicine’s FoundationOne CDx (F1CDx), the first breakthrough-designated, next generation sequencing-based in vitro diagnostic test that can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor type. An agency news release says that compared to other companion diagnostics
FDA Policy/General
Federal Register notice: FDA has announced a 1/30-31/2018 public workshop entitled “Fostering Digital Health Innovation: Developing the Software Precertification Program.” The workshop is intended to discuss the progress of the agency’s pilot precertification program and to seek input on the program’s ongoing development. The program
FDA Policy/General
Federal Register notice: FDA has announced a 3/15/2018 public meeting entitled “Oncology Center of Excellence (OCE): Listening Session” that is intended for stakeholders to provide input on the Center’s functions. Specifically, the agency seeks comments on OCE’s structure, function, regulatory purview, and activity. To view the
Drugs
Mylan has petitioned FDA to require specific bioequivalence study designs for ANDA applicants seeking to market generic versions of GlaxoSmithKline’s asthma therapy Advair Diskus (fluticasone propionate and salmeterol xinafoate) inhalation powder. The Mylan petition asks FDA to refrain from approving any ANDA that “relies on multiple-batch pharmacokinetic (PK)
Drugs
Senator Elizabeth Warren (D-MA) has introduced the National Biomedical Research Act that would increase funding for targeted biomedical research initiatives through a new, reliable funding stream supporting both NIH and FDA. The bill would provide $5 billion annually in supplemental funding for grants for young emerging scientists, and breakthrough
FDA Policy/General
Federal Register notice: FDA is seeking comments on a statement of work to assess current practices when communicating during IND development and identify best practices and areas of improvement. The independent assessment is part of the agency’s user fee performance commitments. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has released its annual report on the status of drug/biologic postmarketing requirements and postmarketing commitments on studies and clinical trials that applicants have agreed to, or are required to, conduct. To view the notice, click here.
Devices
FDA has cleared a Genea Biomedx 510(k) for its benchtop incubator Geri. The continuous embryo monitoring benchtop incubator is designed to offer undisturbed incubation for embryos during in vitro fertilization treatment. Genea Biomedx says the device is used with the company’s Geri culture medium to provide a continuous
Drugs
The Washington Legal Foundation (WLF) is urging FDA to replace all older guidances with formal regulations that undergo a notice-and-comment rulemaking process. “Perhaps more importantly, FDA should adopt a strict rule requiring that all draft guidances not adopted in final form within two years of initial issuance must
Drugs
Federal Register notice: FDA has extended the comment period on a 10/3 draft guidance entitled “ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.” Comments can now be submitted in electronic or written form by 2/4/2018. The document is
FDA Policy/General
FDA commissioner Scott Gottlieb says that across multiple science fields, “we stand at an inflection point in medicine — where new technology is creating foundational opportunities to treat and cure disease in ways that weren’t possible just a short time ago.” He made these remarks during a 12/7 Senate
FDA Policy/General
CNN reports that Otsuka subsidiary Avanir Pharmaceuticals paid a number of doctors who had been disciplined by state medical boards or even had criminal convictions to promote its Nudexta, which is approved by FDA to treat pseudobulbar affect. The network’s investigation found repeated examples of the drug being prescribed
Drugs
An analysis by the Centers for Medicare and Medicaid Services (CMS) Office of the Actuary shows that national spending for prescription drugs rose just 1.3% in 2016, compared to 12% in 2014 and 9% in 2015. Kaiser Health News says in a summary that the report attributes the deceleration
Devices
FDA commissioner Scott Gottlieb says the agency has issued two draft and one final guidance to “continue to expand our efforts to encourage innovation in the ever-changing field of digital health. Our aim is to provide more clarity on and innovative changes to our risk-based approach to digital
Drugs
The Duke University Margolis Center for Health Policy is launching a Real-World Evidence Collaborative to advance policy development related to the regulatory acceptability of real-world evidence (RWE). A statement says the collaborative will “engage major stakeholders to help advise and guide high priority efforts aimed at improving the