FDA Policy/General
Federal Register Notice: FDA is seeking comments on a new information collection under its “Process for Collecting Nominations of Candidates to Serve on FDA’s Advisory Committees.” In order to identify and select qualified individuals to serve on its advisory committees, FDA has established an online portal, the FDA Advisory
Drugs
A review of cases that president Donald Trump’s U.S. Supreme Court nominee Neil Gorsuch has decided shows that he is supportive of the federal preemption doctrine that could serve the medical product industry well when defending product liability lawsuits, according to the Drug & Device Law blog. The
FDA Policy/General
The “rogue” FDA employees (see earlier story) running an alternative Twitter handle — @alt_fda — have uploaded to the cloud an archive of inspection citations that date back to FY 2006 because they fear the data sets could be removed from FDA’s Web site. In a 2/2 Twitter post,
Devices
Medical device lobbying group AdvaMed continues to oppose adding unique device identifier (UDI) information to insurance claims forms. The opposition follows a recommendation by an advisory committee for Accredited Standards Committee X12 that a UDI device identifier should be a required field on a claims form when a “high-risk
FDA Policy/General
FDA says it is modifying the process on how it collects and posts curricula vitae (CVs) of advisory committee members so that they will be posted to its Web site without removing or redacting any information. “Posting CVs without removing or redacting any information will increase the transparency of FDA’
Drugs
FDA has issued Charleston Laboratories and Daiichi Sankyo a complete response letter (CRL) on their NDA for CL-108 (hydrocodone, acetaminophen, promethazine), an investigational treatment for managing pain severe enough to require an opioid analgesic while preventing or reducing the associated opioid-induced nausea and vomiting when alternative treatments for
Drugs
House Energy and Commerce Committee chairman Greg Walden (R-OR) says a yet-to-be-announced health subcommittee hearing next week will take up a bill being drafted to effect lower drug prices through better generic drug competition. During a 2/2 hearing, Walden said he would push for the
Biologics
FDA has accepted for review two Merck supplemental BLAs for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy in patients with locally advanced or metastatic urothelial cancer. Specifically, the application for first-line use was accepted and granted priority review for treating patients who are ineligible for cisplatin-containing
Devices
FDA has permitted the marketing under the de novo process of Baebies Inc.’s Seeker System for screening four rare Lysosomal Storage Disorders (LSDs) in newborns. The device is designed to detect Mucopolysaccharidosis Type I (MPS I), Pompe, Gaucher and Fabry. It is the first newborn screening test permitted to
FDA Policy/General
The U.S. Office of Management and Budget (OMB) has released guidance on the Trump Administration’s hiring freeze that appears to give latitude to agencies, like FDA, to exempt hiring decisions when the hire will help meet public health responsibilities. The guidance says agency heads should consult with appropriate
Devices
FDA has granted Abbott an emergency use authorization for its Abbott RealTime ZIKA test, a molecular test for detecting Zika virus in whole blood (when collected alongside a patient-matched serum or plasma sample). “This is the first molecular test made by a commercial manufacturer authorized to detect Zika in
FDA Policy/General
A microsurvey of doctors by marketing research firm InCrowd finds that doctors say that direct-to-consumer prescription drug ads are succeeding in delivering more inquisitive patients. Respondents expressed concern, however, about the way in which ads shape patient understanding. InCrowd says that doctors reported three times the number of
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) issued 11 letters to companies in 2016, slightly more than in 2014 and 2015. An online survey by Eye on FDA finds that there were three Warning Letters and eight Notices of Violation last year. All 11 involved only a single communications
Drugs
FDA has released the FDA-483 issued at the conclusion of a 1/16-1/24 inspection at Natco Pharma, Telangana, India. Specific inspection observations included: * failing to fully follow responsibilities and procedures applicable to the quality control unit; * failing to follow the written stability testing program; * failing to have
Drugs
Three Akin Gump attorneys say that examples included in an FDA draft guidance on consistent communications “appear to signal a slight thawing in FDA’s approach to communications made related to drugs, particularly with respect to information about longer-term safety and efficacy, specific patient subgroups, patient-reported outcomes, and
Drugs
The pharmacist in tiny Kermit, WV (pop. 392) was making $500,000 a month selling opioids and the five drug wholesalers, including the nation’s three largest, supplying him knew it ꟷ yet they illegally looked away and kept shipping more and more, “motivated by profit and greed.” So alleges
Drugs
Biomedical ethics researchers from Canada’s McGill University say that the efficacy of drugs should be considered before they are allowed to enter first-in-human trials. Writing in a Nature commentary, the ethicists say that “more thorough assessments of clinical potential before trials begin could lower failure rates and
Drugs
FDA has accepted for priority review an AbbVie NDA for its investigational, pan-genotypic regimen of glecaprevir/pibrentasvir (G/P) for treating all major genotypes of chronic hepatitis C virus (HCV). The submission is supported by data from eight registration studies in AbbVie's G/P clinical development program,
Drugs
It would be unwise to speed up drug development and approvals by reducing or eliminating Phase 2 or Phase 3 trials, according to an opinion piece in The Scientist. Written by two academics(*), the article cautions that such an approach would not test the drugs in a sufficient number of
Drugs
Impax Laboratories has filed a petition urging FDA to refuse to receive or approve any ANDA seeking approval to market a generic version of Rytary (carbidopa and levodopa) extended-release capsules unless the generic drug applicant has demonstrated bioequivalence to Rytary through scientifically appropriate methods outlined in the document. The
Drugs
A group of government scientists is warning president Trump that politics have no place in science, and any restrictions on scientific findings will lead to widespread leaks of information and embarrassment for the administration. A 1/31 letter from Public Employees for Environmental Responsibility called out the Trump administration and
Drugs
President Trump’s promise to the pharmaceutical industry to massively gut FDA’s regulations in exchange for lower drug costs for the American people would “fundamentally destroy the ability of the agency to protect patients and consumers from unsafe or ineffective medications and medical devices, hazardous foods and dietary supplements,