Drugs
Ultragenyx says its aceneuramic acid extended release (Ace-ER) drug did not achieve its primary endpoint in a Phase 3 clinical trial in patients with GNE myopathy. The company says it is terminating its development program based on the Phase 3 results. The primary endpoint called for the therapy to
FDA Policy/General
Federal Register notice: FDA is seeking comment on an information collection entitled “Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded — 21 CFR 330.14.” FDA regulations at 21 CFR 330.14 establish additional criteria and procedures for classifying
FDA Policy/General
Federal Register notice: FDA has announced a 9/28 Peripheral and Central Nervous System Drugs Advisory Committee meeting. Panel members will discuss and vote on a PTC Therapeutics NDA for ataluren for oral suspension, indicated for treating patients with dystrophinopathy due to a nonsense mutation in the dystrophin gene. To
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Bicooya Cosmetics Ltd. Zhejiang, China (8/11): FDA inspected the firm’s drug manufacturing facility in May and cited it for significant GMP violations with finished pharmaceuticals. For example,
Drugs
ChromaDex, which says it is the only supplier of nicotinaminde riboside chloride (Niagen) that has been recognized by FDA as generally safe (GRAS), is asking the agency to investigate and take appropriate remedial action against Elysium Health over its Basis dietary supplement. The ChromaDex petition says that in the past,
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Medical Devices; Exception From General Requirements for Informed Consent.” In 2006, FDA issued an interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use
FDA Policy/General
Federal Register notice: FDA has announced a 9/11-12 Pediatric Advisory Committee meeting in Rockville, MD. Panel members are scheduled to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. To view the notice, click here.
Drugs
Pfizer is asking FDA to issue a product-specific bioequivalence (BE) guidance applicable to any ANDA for a generic version of its Estring (estradiol vaginal ring), and to require any ANDA applicant to establish bioequivalence for its generic Estring product based on the conditions set forth in such a guidance.
Biologics
FDA says that Organogeneris has failed to submit a pediatric assessment for its Gintuit (allogenic cultured keratinocytes and fibroblasts in bovine collagen) allogenic oral soft tissue product as required under the Pediatric Research Equity Act (PREA). The need for the study was included in the agency’s 3/9/12
Drugs
FDA says it approved 8/21 changes to labeling for Guilead’s Odefsey (emtricitabine/rilpivirine/tenofovir/alafenamide HIV-1 treatment. The changes add data from 48-week trials in which subjects switched to Odefsey from tenofovir disoproxil fumarate-based regimens such as Gilead’s Complera or Bristol-Myers Squibb’s
Drugs
FDA has told Cardiome Pharma that a data package proposed by the company would not be sufficient to support a resubmission of its NDA for Brinavess (vernakalant hydrochloride, IV), an antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation. “In our most recent communication with the FDA, we
FDA Policy/General
Federal Register notice: FDA has established a public docket to assist with its development of recommendations on the communication of risk information in direct-to-consumer broadcast advertisements for prescription drugs and biologics. To view the notice, click here.
Drugs
With President Donald Trump signing the FDA Reauthorization Act 8/18, FDA says it will revise an earlier draft guidance on pre-submission of facility information as part of an expedited review of qualifying priority ANDAs. The reauthorization law includes provisions providing for the expedited review of qualifying priority ANDAs
Devices
FDA has recognized the UL 2900-1 cybersecurity standard for medical devices, according to Emergo Group. In an online post, the company says that the standard covers general cybersecurity requirements for network-connectable devices. According to Emergo, FDA medical device applicants may declare conformity to UL 2900-1 to address
Devices
FDA’s Office of Pediatric Therapeutics has announced a 9/18-19 public workshop entitled “Advancing the Development of Pediatric Therapeutics (ADEPT): Application of ‘Big Data’ to Pediatric Safety Studies.” The workshop’s goal is to understand how to access and analyze “big data” associated with safety information in the
Drugs
AdvaMed says the current 2003 FDA guidance on using electronic records and signatures in medical product clinical investigations is outdated and uses enforcement discretion. In its comment on a new draft guidance, the trade association says it supports the risk-based approach to validation and audit trails outlined in the
FDA Policy/General
Federal Register final rule technical amendment: FDA is amending the Medical Device Classification Procedures regulation to reflect a change in address for CDRH. The mailing address is revised as follows: Center for Devices and Radiological Health, Regulations Staff, Document Mail Center – WO66–G609, 10903 New Hampshire Ave., Silver Spring, MD
Drugs
President Trump has signed the FDA Reauthorization Act of 2017 that renews the agency’s user fee programs for another five years. Enacting the measure into law removes the threat of having to send reduction-in-force (RIF) notices to staff who are funded by user fees. In late July,
Drugs
FDA says it is carefully evaluating prescription opioid medications approved to treat cough in children, and it has planned a 9/11 Pediatric Advisory Committe meeting to discuss the topic and receive panel recommendations. “There are few more common decisions that parents and providers are asked to make than the
FDA Policy/General
Federal Register notice: FDA has determined for patent restoration purposes the regulatory review period for Acrux DDS Pty. Ltd.’s Recuvyra (fentanyl), indicated for controlling postoperative pain associated with surgical procedures in dogs. The applicable regulatory review period for Recuvyra is 2,092 days, which includes 2,037 days during
Drugs
A July inspection at outsourcing drug manufacturer Leesar, Inc. (Fort Myers, FL) found that the firm’s aseptic processing areas were deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. According to a just-posted Form 483, procedures designed to prevent microbiological contamination
FDA Policy/General
Federal Register notice: FDA has announced the availability of a draft guidance on “Identifying Trading Partners Under the Drug Supply Chain Security Act.” The document provides recommendations on how to categorize entities in the drug supply chain in accordance with this law. It also explains how to determine when certain