Devices
FDA has updated its guidance on developing and responding to deficiencies in accordance with the least burdensome provisions that was first issued 17 years ago. Attorney Adrienne Lenz (Hyman, Phelps & McNamara) says in an online post in her firm’s FDA Law Blog that the revised guidance sets forth
Biologics
FDA's Cellular, Tissue and Gene Therapies Advisory Committee has voted unanimously (16 to 0) to recommend approval for a Spark Therapeutics BLA for Luxturna (voretigene neparvovec) for treating patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy. A briefing document released in advance of
FDA Policy/General
Federal Register notice: FDA is correcting a final order entitled “Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device” that appeared in the 7/28 Federal Register. The correction notes that for this type of device, FDA has determined that premarket notification is necessary to provide reasonable assurance of
FDA Policy/General
Federal Register notice: FDA has announced a 3/21/2018 public meeting on “Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.” Topics to be discussed will include the current status of electronic submissions and data standards initiatives to improve the predictability and consistency of the electronic
Drugs
FDA medical reviewers say that Aerie Pharmaceuticals’ Rhopressa (netarsudil ophthalmic solution 0.02%) is effective for its proposed indication of reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. A briefing document released in advance of a 10/13 meeting of the FDA Dermatologic and Ophthalmic
Drugs
To meet a statutory time deadline, FDA has denied a 5/15 AstraZeneca petition asking for specific agency action involving the company’s Falsodex (fulvestrant) intramuscular (IM) injection without commenting on whether it will ultimately take the requested actions. The AstraZeneca petition cited a Teva 505(b)(2) NDA referencing
Drugs
A PriceWaterhouseCoopers Health Research Institute (HRI) report says the drug industry is facing a growing threat from safety data on drugs being produced. “FDA has fostered unprecedented transparency on drug safety data,” the report says, “forcing companies to manage novel challenges from parties already busy mining those data: regulators, the
Drugs
FDA has issued a draft guidance, Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017, to explain the new PDUFA 6 user fee structure and the types of fees for which entities are responsible. The document describes the types of user fees authorized by PDUFA 6, the
Drugs
FDA has issued a draft guidance, Determining Whether to Submit an ANDA or a 505(b)(2) Application, to assist applicants to determine which one of the abbreviated approval pathways under the Federal Food, Drug, and Cosmetic Act (FFDCA) is appropriate for the submission of a marketing application to FDA.
Drugs
Merck says it will not seek FDA regulatory approval for anacetrapib, an investigational cholesteryl ester transfer protein (CETP) inhibitor for lowering cholesterol. The company says its decision follows a thorough review of anacetrapib’s clinical profile, including discussions with external experts, concluding that the “clinical profile for anacetrapib does not
Drugs
FDA has issued a draft guidance, Requests for Reconsideration at the Division Level Under GDUFA, with recommendations for industry on the procedures for resolving scientific and/or regulatory issues or matters between FDA and ANDA applicants at the division level or original signatory authority. The document does not describe the
Drugs
FDA says that to address critical drug shortages in the aftermath of Hurricane Maria, Baxter Healthcare Corp. is coordinating with the agency to increase the availability of products from the company’s manufacturing facility in Ireland. An FDA notice lists the four IV products the company is temporarily importing and
Drugs
FDA has issued a draft guidance, Format and Content of a REMS Document, with updated recommendations for the format and content of a risk evaluation and mitigation strategy (REMS) document for a prescription drug product, including biological products. The document provides recommendations to applicants on drafting proposed REMS documents and
FDA Policy/General
FDA commissioner Scott Gottlieb, mentioned as a possible successor to Tom Price as HHS secretary, says he believes he can be more effective on behalf of the Trump administration in his current position. In a 10/10 interview with Reuters, Gottlieb declined to say whether he had any conversations with
Drugs
Janssen Biotech has submitted an NDA for apalutamide, an investigational, next-generation oral androgen receptor inhibitor for men with non-metastatic castration-resistant prostate cancer (CRPC). Currently, no FDA approved treatments exist for these men. The company says apalutamide works by inhibiting the action of testosterone in prostate cancer cells
Devices
Philips North America has agreed to a consent decree with FDA that will see the company suspending external defibrillator manufacturing at its Andover, MA, and Bothell, WA facilities. The decree follows inspections in 2015 and before that documented GMP issues, according to the company. Earlier this year, Phillips recalled its
Drugs
The Biotechnology Innovation Organization (BIO) says that FDA could minimize ambiguity when it finalizes a draft guidance, “Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes for Specified Biological Products to Be Documented in Annual Reports,” by giving examples of situations where annual reportable listed changes in the guidance may be better
Drugs
FDA has awarded contracts to two companies to help the agency better determine how to collect more scientifically valid data in postmarketing studies of opioid abuse deterrence in real-world evidence. An online conversation with CDER Office of Surveillance and Epidemiology associate director for public health initiatives Judy Staffa indicates
FDA Policy/General
Malin Corp. has appointed former FDA commissioner Andrew von Eschenbach as the company’s chief medical advisor. Previously, he served as an advisory partner to Malin. Von Eschenbach currently wears many hats — serving as president of Samaritan Health Initiatives Inc. and an adjunct professor at Houston’s University of Texas
Drugs
FDA has published a draft guidance on “Respiratory Syncytial Virus (RSV) Infection: Developing Antiviral Drugs for Prophylaxis and Treatment” that addresses the agency’s current thinking about the overall development program and clinical trial designs for such products. It focuses primarily on the development of drugs with antiviral mechanism for
Devices
Abbott subsidiary St. Jude Medical has recalled its Unify and Unify Assura cardiac resynchronization therapy defibrillators due to battery issues. The devices may exhibit premature battery depletion, an FDA recall notice says. The products are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-
Devices
A 1/16-1/19 FDA inspection at Euro Diagnostica AB, Skane, Sweden, found Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of multiple Class 2 in vitro diagnostic devices, including the Euro-Diagnostica CCPoint. A 9/20 Warning Letter says the violations were: * failing