Devices
Exeed, a medical device consulting firm, says FDA is changing the way it interacts with violative medical device firms to evaluate and help them develop an appropriate plan of corrective action. In a blog post, Exeed says that the agency’s subtle change in its use of Warning Letters is
Drugs
A 10/22-10/26/18 FDA inspection at Centurion Laboratories Private Limited, Manjusar, Gujarat, India, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. A just-released 4/5 Warning Letter says the specific violations were: * failing to ensure that laboratory records include complete data derived
Devices
An 11/6-11/9/18 FDA inspection at Zeller Power Products’ medical device operations in Las Vegas, NV, found Quality System Regulation and other violations in the firm’s manufacturing of Class 3 automated external defibrillator batteries intended to replace the original equipment manufacturer battery used in Cardiac Science
Drugs
Two staffers in the CDER Office of Surveillance and Epidemiology say they are aware of instances in which prescription drug litigation has had significant impacts on signals of disproportionate reporting (SDRs) to the FDA Adverse Event Reporting System (FAERS). Writing online in the journal Drug Safety, the two identified litigation-
Devices
A 2/4-2/15 FDA inspection at Orchid Orthopedic Solutions, Farmington Hills, MI, found Quality System Regulation violations in the firm’s work as a medical device manufacturer specializing in applying coatings to orthopedic implants that promote bone ingrowth. A 5/13 Warning Letter says the specific violations were:
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it believes that increasing patients’ awareness of and access to clinical trials are critical factors in making drug development innovation possible. Responding to an FDA 3/18 workshop on enhancing the incorporation of patient perspectives on clinical trials, the industry group says
Devices
FDA has cleared a Body Vision Medical 510(k) for the LungVision 2.0 System. The new device features “real-time tool-in-lesion confirmation combined with seamless integration of LungVision Tool, a disposable lung navigation catheter,” according to the company. The LungVision Tool, which is guided by the LungVision
Drugs
A white paper, “Designing the Future of Cell Therapies,” produced by Friends of Cancer Research and the Parker Institute for Cancer Immunotherapy, says there is great interest in exploring new treatment modalities to encompass treatment of solid tumors, which comprise 90% of all cancers and the majority of cancer deaths.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Centurion Laboratories Private Gujarat India (4/5): FDA inspected the firm 10/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to ensure that
Devices
A revised safety update on Abiomed's Impella RP System emphasizes proper patient selection after interim post-approval study (PAS) results indicated a lower survival rate for the subgroup of PAS patients who would not have qualified for inclusion in clinical studies performed before the device was approved. The
Biologics
FDA has released a draft guidance on “Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations.” The document describes the agency’s recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product is biosimilar to
Drugs
Former FDA commissioner Scott Gottlieb says the nation’s healthcare system needs to rethink how drugs and other therapies are paid for. “The drug debate is often focused on price,” he writes in a CNBC commentary. “But the real imperative turns on questions of access. Drugmakers have a compact with
Drugs
An FDA inspection last month of Cadila Healthcare’s Gujarat, India manufacturing facility has led to a 23-page Form 483 that cites significant GMP violations. For example, the agency said the firm’s equipment and utensils were not cleaned and maintained at appropriate intervals to prevent contamination. The inspection
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Exports: Notification and Recordkeeping Requirements — 21 CFR 1.101” (OMB Control Number 0910-0482). The federal Food, Drug, and Cosmetic Act provides FDA with the responsibility of helping to ensure that exports of unapproved new drugs, biologics,
Devices
For a decade, Medtronic was allowed by FDA to report thousands of adverse events associated with the company’s Sprint Fidelis defibrillator under a publicly-shielded “alternative summary reporting” program, according to a Kaiser Health News (KHN) report posted on CNN.com. Faced with criticism, FDA has ceased the alternative
Devices
FDA has approved a Stryker PMA for the Neuroform Atlas Stent System, an aneurysm adjunctive stent for treating wide-neck, intracranial aneurysms in conjunction with embolic detachable coils. The device was previously approved under a humanitarian device exemption restricting use to specific hospitals with institutional review board approval. Approval was
FDA Policy/General
Federal Register notice: FDA has announced it has modified organizational structures in the Office of the Commissioner, headquarters organizations, and product Centers. The Office of the Commissioner reorganization will transition the agency away from the directorate structure to realign many functions to the Centers/Office of Regulatory Affairs (ORA). It
Drugs
The U.S. Supreme Court has unanimously ruled that FDA preemption questions are for a judge to decide, not a jury. In a 5/20 opinion in a Merck product liability lawsuit involving osteoporosis drug Fosamax, the high court reiterated that “clear evidence that the FDA would not have approved
Devices
FDA has cleared a Qiagen 510(k) for the multiplex QIAstat-Dx Respiratory Panel for simultaneous qualitative detection and identification of multiple respiratory viral and bacterial pathogens. The next-generation multiplex molecular diagnostic system, which is based on the company’s proprietary DiagCore technology, can detect more than 20 pathogens.
Drugs
FDA has approved an Akorn ANDA for a generic copy of Meda Pharmaceuticals’ Astelin (azelastine hydrochloride) nasal spray, 0.1%, indicated for treating symptoms of seasonal allergic rhinitis in adults and pediatric patients aged five years and older, and for treating symptoms of vasomotor rhinitis in adults and adolescent patients
Drugs
FDA has approved an Akorn ANDA for a generic copy of Meda Pharmaceuticals’ Astelin (azelastine hydrochloride) nasal spray, 0.1%, indicated for treating symptoms of seasonal allergic rhinitis in adults and pediatric patients aged five years and older, and for treating symptoms of vasomotor rhinitis in adults and adolescent patients
FDA Policy/General
Info Collection Extension for Drug Patent Listings Federal Register notice: FDA seeks comments on an information collection extension for “Applications for Food and Drug Administration Approval to Market a New Drug: Patent Submission and Listing Requirements.” 05/17/2019 Fed Reg Correction on Device Accessories Federal Register notice: FDA corrects