Drugs
FDA has published a guidance, Systemic Antibacterial and Antifungal Drugs: Susceptibility Test Interpretive Criteria Labeling for NDAs and ANDAs, with recommendations on fulfilling new labeling requirements for susceptibility test interpretive criteria for prescription systemic antibacterial and antifungal drugs as established by the 21st Century Cures Act. Included are the agency’
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The American Hospital Association says there are actions FDA could take to reduce the regulatory burden on hospital and health systems and their patients regarding drug compounding and medical device cyber issues. The association’s comment letter recommends: * elimination of a provision in a 4/2016 FDA draft guidance that
Drugs
The Biotechnology Innovation Organization (BIO) says a draft FDA guidance on format and content of a Risk Evaluation and Mitigation Strategy (REMS) document should include additional requirements for REMS programs run or administered through specialty pharmacy healthcare settings. The additional requirements should include enhanced/expanded communication with prescribers and/or
Drugs
Tremeau Pharmaceuticals says it has recently reached agreement with FDA on the development requirements to support an NDA for TRM-201 (rofecoxib), indicated as a as a non-opioid pain alternative for treating hemophilic arthropathy (HA). Rofecoxib was once marketed by Merck as Vioxx, but it was pulled from the
Drugs
A 5/25-5/26 FDA inspection at Seindni Co., Seoul, Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 12/5 Warning Letter. The letter says the agency investigators found that the company failed to establish a quality control unit and
Drugs
FDA has issued a draft guidance, Gluten in Drug Products and Associated Labeling Recommendations, to give drug manufacturers agency recommendations on how certain drug products should be labeled regarding gluten. “Some individuals with celiac disease have faced difficulty when trying to determine whether specific drug products contain gluten,” the document
Drugs
FDA has issued a draft guidance, Refuse to File: NDA and BLA Submissions to CDER, to clarify circumstances under which CDER may refuse to file new or supplemental NDAs and BLAs for therapeutic products regulated by the Center. The guidance also is to underscore the importance of submitting a complete
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Fagron Compounding Services Wichita, KS (11/28): FDA inspected the outsourcing drug facility in 2016 and cited serious deficiencies in its practices for producing sterile drug products. For example,
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
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
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
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
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
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
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
Drugs
FDA has asked Primus Pharmaceuticals (Scottsdale, AZ) to recall Limbrel, a capsule marketed to “manage the metabolic processes associated with osteoarthritis.” The agency says the product is marketed as a medical food, but a preliminary determination suggests that Limbrel is an unapproved new drug. A safety alert notes that so
Drugs
CDER Office of New Drugs deputy director Peter Stein says it is important for the public to know that most drug post-approval studies are on track. “When studies are delayed,” he says in an FDA Voice blog post, “FDA works with manufacturers to identify the reasons for the delays