FDA Policy/General
A House Energy and Commerce subcommittee heard differing opinions 7/12 on whether to advance two bills that would open up FDA’s regulatory framework to allow more dissemination of truthful and non-misleading off-label information about drugs and devices. Representing the Medical Information Working Group, Sidley Austin partner
Drugs
The House of Representatives 7/12 passed a bill (voice vote) to reauthorize medical product user fee programs for another five years beginning 10/1. Congress had made passage a priority in order to prevent layoff notices being issued to 5,000 agency employees, which reportedly could happen later this
Drugs
A 9/19-23/16 FDA inspection at Vista Pharmaceuticals, Nalgonda, Telangana, India, found significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals, according to a 7/5 Warning Letter. The letter also says that an agency review of labeling provided by the company determined that its isoxsuprine
FDA Policy/General
Federal Register notice: FDA is requesting comment on draft standardized Pharmaceutical Quality/Chemistry Manufacturing and Control (PQ/CMC) data elements and terminologies for electronic submission. Standardized data elements and terminologies will provide opportunities for FDA and industry to transform PQ/CMC submission data into a readily useable electronic format. As
Drugs
Vifor Fresenius Medical Care Renal Pharma is asking FDA to refuse to approve a Keryx Biopharmaceuticals sNDA to add an indication for its Auryxia “because of multiple, serious safety concerns.” The company markets several products that could be impacted if the sNDA is approved. A 6/30 petition says the
FDA Policy/General
Federal Register notice: FDA has determined that the regulatory review period for Cerus Corp.’s Intercept Blood System For Plasma is 6,497 days, which includes 6,114 days during the testing phase and 383 days during the approval phase. The determination was made pursuant to applications submitted to the
FDA Policy/General
Federal Register notice: FDA has determined that the regulatory review period for Cerus Corp.’s Intercept Blood System for Platelets is 7,080 days, which includes 6,909 days during the testing phase and 171 days during the approval phase. The determination was made pursuant to applications submitted to the
FDA Policy/General
Federal Register notice: FDA has announced a list of 1,003 Class 2 devices that it has determined no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations. This notice represents FDA’s final determination on a proposed list of devices published 3/
Drugs
FDA has cleared a Stryker 510(k) for its MultiGen 2 RF Generator for performing radiofrequency ablation to provide relief from facet joint pain. The device was designed with double the industry standard for power, according to the company, and it achieves target temperature faster, with fewer errors, than current
Drugs
CDER director Janet Woodcock says that two recent agency drug approvals “point to an encouraging future for precision medicine — an approach for disease treatment that tailors medical therapies, including medications, to the needs of individual patients.” Writing in an FDA Voice blog post, Woodcock cited the approvals of Vertex’ Kalydeco
Drugs
Washington Legal Foundation (WLF) says the 4th Circuit Court of Appeals should uphold a South Carolina federal court ruling dismissing a multi-district suit against Pfizer over its Lipitor marketing, sales practices, and product liability. In an amicus brief, WLF says it “believes that the quality of decision-making in
Drugs
Friends of Cancer Research president Jeff Allen says that so many drug labels are out of date that it has become a serious public health problem. In a statement, Allen says Congress should fix the problem by using the Prescription Drug User Fee Act reauthorization to broaden FDA’s authority
Drugs
FDA has released the FDA-483 from an 8/16-17/2016 agency inspection at Zhejiang Bangli Medical Products Co., Yongkang City, China. The report contains these 11 inspection observations: * there is no quality unit; * production batch records do not include complete data; * there is no final disposition decision for
Devices
The Washington Supreme Court has held that a medical device manufacturer has a duty to warn hospitals, and not just doctors, about the potential dangers of a device. A Washington Legal Foundation Legal Opinion Letter says the decision “represents a significant and unwarranted expansion of the duty to warn under
Drugs
The Government Accountability Office (GAO) says that FDA and stakeholders, including a non-profit organization and a drug manufacturer, have taken steps to improve the agency’s expanded access process and patient access to drugs. The statement is in a report on GAO’s evaluation of the expanded access program
Drugs
FDA has abandoned a requirement imposed on Amicus Therapeutics to conduct an additional Phase 3 study to assess gastrointestinal symptoms with its oral precision medicine migalastat for Fabry disease, a move that now opens a path for an NDA filing in the fourth quarter seeking accelerated approval. The European Commission
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. New Capstone Kihei, HI (6/27): FDA reviewed the firm’s Web site (www.rnareset.com) in May and determined that its products (ReMyte, ReAline, ReMag, ReStructure, and ReCalcia
Drugs
FDA commissioner Scott Gottlieb has hinted that more approved opioid products could be withdrawn from the market if the agency determines through post-market information that a product’s risks outweigh its benefits. Last month, the agency asked Endo Pharmaceuticals to remove its Opana ER (oxymorphone hydrochloride) opioid pain medication
Drugs
FDA has agreed to a consent decree of permanent injunction against Medistat RX LLC (Foley, AL), the company’s co-owners, Mark D. Acker and Timothy L. Fickling, and quality manager and pharmacist-in-charge V. Elaine Waller. The court order “prohibits Medistat, its owners and pharmacist-in-charge from
FDA Policy/General
The House Energy and Commerce Subcommittee on Health has announced a 7/12 hearing on “Examining Medical Product Manufacturer Communications.” It is planned to provide “members an opportunity to better understand how medical products are often prescribed and administered for uses that are not included in the labeling approved by
Devices
FDA says that it has not received any additional adverse events associated with severe bleeding and hematomas with axter International’s Vascu-Guard peripheral vascular patch during carotid endarterectomy (CEA) since the agency sent a 9/2016 letter to health care providers. Baxter conducted a recall of the device 6/
Drugs
FDA has approved an Emmaus Medical NDA for Endari (L-glutamine oral powder) for patients five years and older with sickle cell disease to reduce severe complications associated with the blood disorder. “Endari is the first treatment approved for patients with sickle cell disease in almost 20 years,” CDER Oncology