Biologics
FDA has posted a draft guidance on “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” The document explains changes to the user fee program mandated under the Reauthorization Act of 2017, particularly the new fee structure and types of fees for which entities are responsible. It describes
Drugs
FDA has cleared an Alcyone Lifesciences 510(k) for the Alivio Ventricular Catheter and Flusher System for treating hydrocephalus. This comes on the heels of Alcyone receiving the EU CE Mark last month. The device is intended to provide clinicians with the option of non-invasive retrograde flushing of the
Drugs
FDA has approved an Ultragenyx Pharmaceutical NDA for Mepsevii (vestronidase alfa-vjbk), the first approved treatment for pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. MPS VII is an extremely rare, progressive condition that affects most tissues and
FDA Policy/General
FDA commissioner Scott Gottlieb says an FDA Hiring Initiative will reimagine the agency’s hiring practices and procedures with the goal of attracting, recruiting, and hiring and retaining professionals who support FDA’s mission. Writing in an FDA Voice blog post, Gottlieb says a comprehensive evaluation of hiring practices and
Devices
FDA has authorized Memorial Sloan Kettering Cancer Center’s IMPACT (integrated mutation profiling of actionable cancer targets) tumor profiling test, an in vitro diagnostic assay that can identify a higher number of biomarkers than may be found in various cancers with any test previously reviewed by the agency. IMPACT was
Drugs
A 3/27-4/7 FDA inspection at the Lupin Limited drug manufacturing facility in Goa, India, and a 5/8-5/19 inspection at the facility in Indore, Madhya, Pradesh, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals at each plant, according to an
FDA Policy/General
FDA direct-to-consumer ad researchers say their content analysis of 50 television direct-to-consumer (DTC) prescription drug ads airing between 7/2012 and 8/2014 suggests an unintended consequence of a focus on risk completeness without an accompanying focus on understandability. The study analysis is reported in the
Drugs
FDA has approved an Otsuka Pharmaceutical NDA for mental disorder-treating Abilify MyCite (aripiprazole tablets with sensor) — the first drug-device combination in the U.S. with a digital ingestion tracking system. The pill has a sensor embedded in it that records when the medication was taken. It is approved
Devices
FDA has issued a safety alert about illegal use of injectable silicone for body contouring and associated injuries and disfigurement that can result from such products. The agency says the injectable silicone products are being falsely marketed as FDA-approved dermal fillers for the purpose of enhancing the size of
FDA Policy/General
Federal Register notice: FDA has classified the automated indirect immunofluorescence microscope and software-assisted system into Class 2 (special controls). The classification is in response to a 2014 de novo classification request from Inova Diagnostics for its NOVA View Automated Fluorescence Microscope. The agency is codifying the classification by adding
Devices
CDRH associate director for science and strategic partnerships Suzanne Schwartz says medical device manufacturers have made “a fair amount of progress that has been very encouraging” in dealing with cybersecurity issues. In an audio interview with the Information Security Media Group, Schwartz says the agency has seen industry be “more
Drugs
FDA commissioner Scott Gottlieb says the agency has issued a public health advisory related to growing concerns about risks associated with use of a botanical substance known as kratom. In a statement, Gottlieb emphasizes that there are no FDA-approved products containing kratom and that no drug manufacturer has filed
Drugs
Yale University and Johns Hopkins University School of Medicine researchers say FDA’s 2006 Unapproved Drugs Initiative (UDI) intended to strengthen the agency’s regulatory oversight of unapproved marketed drugs has led to significant increases in drug prices after UDI regulatory action or approval. Writing in the Journal of the
Biologics
An FDA 4/3-4/28 inspection of RTI Surgical, Alachua, FL, found multiple violations in the firm’s continuing manufacture of a bone graft product consisting of a scaffold composed of human demineralized bone matrix and cortical cancellous chips or strips, copackaged with a redacted isolated bone marrow, cryopreserved
FDA Policy/General
Federal Register notice: FDA has classified the prostatic artery embolization device into Class 2 (special controls). The action was in response to a 2016 BioSphere Medical de novo classification request for the Embosphere Microspheres. The agency has codified the classification by adding 21 CFR 876.5550 and naming the generic
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Lupin Ltd. Mumbai, India (11/6): FDA inspected the firm’s Goa and Indore drug manufacturing facilities in April and May and documented significant GMP violations with finished pharmaceuticals.
Drugs
As expected, President Donald Trump has nominated former Eli Lilly executive Alex Azar as the next HHS secretary, replacing former Rep. Tom Price, who resigned after his extensive use of private and military jets at taxpayer expense was documented. Before joining Lilly, Azar was a deputy HHS secretary under former
Drugs
The president and owner of a Florida pharmacy has pleaded guilty for his role in a compounding pharmacy fraud scheme, which impacted private insurance companies, Medicare and TRICARE. Nicholas A. Borgesano Jr. (New Port Richey, FL), the president and owner of A to Z Pharmacy of New Port Richey, pleaded
Drugs
Theravance Biopharma and Mylan NV have submitted an NDA for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA) as a once-daily, nebulized bronchodilator for treating chronic obstructive pulmonary disease. The submission is supported by the companies’ Phase 3 program — two replicate pivotal Phase 3 efficacy studies and
Drugs
The American Hospital Association (AHA) has urged FDA to intervene and “expedite the resolution of the worsening shortages of small-volume parenteral solutions that are so fundamental to patient care in hospitals.” In an 11/10 letter to FDA commissioner Scott Gottlieb, AHA said the shortages of widely-used, critical
Devices
FDA has cleared a Clinical Genomics and Quest Diagnostics 510(k) for its InSure One, an at-home collection, fecal immunochemical test intended to detect blood in stool. The device detects human hemoglobin in fecal samples to aid in identifying lower gastrointestinal bleeding. It requires sample collection from one bowel
Drugs
FDA has approved an EMD Serono supplemental NDA for a redesigned version of Gonal-f RFF Redi-ject (follitropin alfa injection) pen injector, indicated for inducing ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure. The product