Devices
FDA says it has received numerous Medical Device Reports on adverse events with implanted pumps that may be used for intrathecal administration of pain medicines not approved by the agency for use with the specific implanted pump. An agency safety communication says that while some individual patients may experience relief
Drugs
Eli Lilly has submitted an NDA for lasmiditan for the acute treatment of migraine with or without aura in adults. The company describes the centrally-penetrant, selective serotonin 5-HT1F agonist as “structurally and mechanistically distinct from other approved migraine therapies and lacks vasoconstrictive activity.” The NDA includes data from
Drugs
A California Court of Appeals has reversed a lower court ruling that cases claiming that manufacturers of incretin-based drugs failed to warn consumers that the drugs increase the risk of developing pancreatic cancer were preempted. The lower court had agreed with the manufacturers (Amylin Pharmaceuticals for its Byetta, Lilly
FDA Policy/General
Ultragenyx Pharmaceutical has completed a pre-NDA meeting and plans to submit an NDA for UX007 for treating patients with long-chain fatty acid oxidation disorders in mid-2019. The company says the meeting led to an agreement to include data from a Phase 2 company-sponsored study of UX007
Drugs
Four Harvard Medical School researchers say the hope that rising drug prices could be addressed in part by biosimilars has not been realized for a number of reasons. In an online article for the American Society for Clinical Pharmacology and Therapeutics, the researchers say there are steps the federal government
Devices
FDA has cleared a Lumendi 510(k) for its DiLumen EIP technology with “suture loops” placed in the skirt along the trailing edge of the fore balloon, a modification to improve tissue retraction during therapeutic endoscopy. “This new device feature will help facilitate tissue manipulation for easier dissection and resection
Drugs
FDA has accepted for review an Ardelyx NDA for tenapanor for treating patients with irritable bowel syndrome with constipation. The company says the minimally-systemic small molecule is designed to act locally in the gastrointestinal tract to inhibit the sodium transporter NHE3 and reduce sodium uptake from the gut. The
Devices
A 3/26-3/30 FDA inspection at US Vascular, LLC, Beaverton, OR, found Quality System and Medical Device Reporting violations in the firm’s manufacturing of Class 2 VascuLab devices used in vascular pathology. A just-released 6/7 Warning Letter says violations were: * failing to establish procedures for
Biologics
A 1/16-1/26 FDA inspection at StemGenex Biologic Laboratories, San Diego, CA, determined that the company processes adipose tissue from donors for autologous use and also processes stromal vascular fraction (SVF) that is administered in a variety of ways. A 10/31 Warning Letter says the company says
FDA Policy/General
FDA says it wants to study the impact of prescription drug professional promotion disclosures as they relate to presentations of preliminary and/or descriptive scientific and clinical data in promotional labeling and advertising for oncology products. An 11/14 Federal Register notice says that the use of disclosures “is one
Drugs
The Stericycle Recall Index for the third quarter of 2018 shows that drug recalls increased 19% to 92, although recalled units declined 56% to just over seven million, lower than in 10 of the last 13 quarters. The report says that failed specifications were the top reason based on recalls
Biologics
FDA has accepted for priority review a Genentech supplemental BLA for Tecentriq (atezolizumab) plus chemotherapy (Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) for first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose disease expresses the PD-L1 protein, as determined by biomarker testing.
Drugs
FDA has approved a PolyPid Ltd. IND for it to proceed with a Phase 3 clinical trial involving lead candidate D-Plex[100] for preventing post-cardiac surgery sternal infections. The novel product is designed to provide local anti-bacterial activity directly at the surgical site to prevent surgical site
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension on a guidance for “Medical Device User Fee Small Business Qualification and Certification” (OMB Control Number 0910-0508). The document describes the criteria FDA will use to decide whether an entity is eligible for a reduction in user
Drugs
The Tufts Center for the Study of Drug Development says the global biotech revolution that launched in the early 1980s is continuing, “offering the promise of a cornucopia of novel products to treat a wide range of diseases.” Using data from the center’s Comprehensive Biotech Data Book to be
Drugs
FDA has issued a draft guidance, Nonmetastatic, Castration-Resistant Prostate Cancer; Considerations for Metastasis-Free Survival Endpoint in Clinical Trials, for drug or biological product development programs regulated by CDER and CBER. The document says issues involving metastasis-free survival were discussed at a 2011 Oncologic Drugs Advisory Committee meeting
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. StemGenex Biologic Laboratories San Diego, CA (10/31): FDA inspected the firm in January and cited it for illegally marketing an unapproved cellular product manufactured in a facility with
Drugs
FDA has accepted for review a Shire supplemental NDA to expand the indication of Gattex (teduglutide [rDNA origin]) for injection to pediatric patients (aged 1-17 years old) with short bowel syndrome (SBS) who are dependent on parenteral nutrition support. The drug is currently indicated for treating adult patients with
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new information collection entitled “Surveys and Interviews With Investigational New Drug (IND) Sponsors To Assess Current Communication Practices With FDA Review Staff Under the Sixth Authorization of the Prescription Drug User Fee Act (PDUFA VI).” As part of PDUFA VI, FDA
Devices
CDRH biomedical engineer Ifeanyi Uwemedimo told a CDRH Webinar that comments received on a 2014 draft guidance on benefit risk factors to consider when determining substantial equivalence (SE) in premarket notifications with different technological characteristics fell into three broad groupings. In finalizing the guidance that was issued 9/25, FDA
Drugs
FDA says it wants to amend its regulations to implement a provision of the 21st Century Cures Act and add an exception to informed consent requirements for certain FDA-regulated clinical investigations that present no more than minimal risk to human research participants. If finalized, the proposed rule would allow
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. Approved information collections include “Disclosures in Professional and Consumer Prescription Drug Promotion,” “Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads,” “Reclassification Petitions for Medical Devices,” and “Medical