FDA Policy/General
Federal Register notice: FDA has announced a 1/26/2018 public hearing on its approach to evaluating the safety and efficacy of nicotine replacement therapy products, including how they should be used and labeled. The hearing is intended to obtain input on the appropriate study designs and methods for evaluating
Devices
A 11/17 CDRH webinar provided an update on the Center’s digital health precertification pilot program. The agency says it wants to be transparent throughout the pilot process and will provide regular updates. At this point, it says, meetings have been held with all nine pilot participants to discuss
Drugs
FDA has approved an Advanced Bionics PMA supplement to add an acoustic earhook for its Naída CI Q90 sound processor that transforms the device into a cochlear implant and hearing aid combination. The addition is designed to provide cochlear implant recipients with natural low-frequency hearing, according to the company.
Drugs
New York University journalism professor Charles Seife says that it’s impossible to trust FDA decisions and statements because it “worries more about a drug’s side effect on a company than on a patient.” Writing in a lengthy Scientific American online article, Seife discusses agency efforts to withhold information
FDA Policy/General
Federal Register notice: FDA has determined that the regulatory review period for patent extension purposes for Wellstat Therapeutics’ Xuriden (uridine triacetate), indicated for treating hereditary orotic aciduria, is 8,494 days. Of this, 8,254 days occurred during the testing phase and 240 days occurred during the approval phase. To
Drugs
Merck KGaA and Pfizer have reported that the Phase 3 JAVELIN gastric cancer trial did not meet its primary endpoint of superior overall survival with avelumab compared with physician’s choice of chemotherapy. The trial investigated avelumab as a third-line treatment for unresectable, recurrent or metastatic gastric or gastroesophageal
FDA Policy/General
Federal Register notice: FDA has determined that the regulatory review period for patent extension purposes for Relypsa’s Veltassa (patiromer sorbitex calcium), indicated for treating hyperkalemia, is 2,844 days. Of this, 2,478 days occurred during the testing phase and 366 days occurred during the approval phase. To view
Devices
A 11/16 FDA webinar explained requirements in two recent final guidances on when to submit a 510(k) for a change to an existing device and when to submit a 510(k) for a software change to an existing device. During the program, CDRH acting associate director for regulations
Drugs
FDA has released the FDA-483 issued at the end of a 10/23-11/1 agency inspection at Northridge Hospital’s Dignity Health sterile drug products producer in Northridge, CA. Specific inspection observations were: * the facility design allowed the influx of poor quality air into a highly classified area;
Drugs
The HHS Inspector General (IG) has withdrawn its advisory opinion approval of Caring Voice Coalition, one of the biggest patient assistance charities in the U.S. The coalition, funded almost entirely by drug companies to help patients afford expensive drugs by paying co-insurance payments that can run more than
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” The document updates FDA’s thinking on the appropriate use of comparable performance between a waived user and a
Drugs
Rep. Louise Slaughter (D-NY) has urged FDA to take stronger action to preserve the effectiveness of antibiotics and protect public health. The push comes as the agency continues to develop a draft rule (FDA-2017-N-1197) that would impact how antibiotics sold for use in livestock raised for
Drugs
Pew Charitable Trusts director of public health Elizabeth Jungman says the Drug Quality and Security Act (DQSA), approved by Congress to regulate drug compounding after a catastrophic fungal meningitis outbreak traced to compounded drugs, has made the situation better but still has not been fully implemented and enforced. Jungman says
FDA Policy/General
FDA commissioner Scott Gottlieb says the agency is taking a new approach to tobacco and nicotine through an initiative to lower nicotine in cigarettes and find new ways to support development and regulation of nicotine replacement therapy (NRT) products that help smokers quit. In an online post with CDER director
Drugs
A Tennessee federal court held that a plaintiff’s failure-to-warn case against Boehringer Ingelheim over injuries suffered when taking the firm’s Type-2 diabetes drug Jardiance (empagliflozin) could not be based on adverse event information known before FDA approved the drug, because the company could not have
Devices
FDA has issued a draft guidance, Recommendations for Dual 510(k) and CLIA Waiver by Application Studies, to assist manufacturers in using the Dual 510(k) and CLIA Waiver by Application pathway. The document says use of the guidance is expected to reduce study-related costs and provide time savings
Drugs
A 3/13-3/17 FDA inspection at Dae Young Foods Company, Seoul, Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to an 11/20 Warning Letter. Specific violations cited in the letter were: * failing to visually examine each container of components for
Drugs
Responding to critics who say the FDA Sentinel System lacks important data and has not identified any safety issues, CDER Office of Surveillance and Epidemiology deputy director Robert Ball says Sentinel has been useful in evaluating drug safety and can also contribute important information for labeling actions, responses to citizen
FDA Policy/General
A new Public Citizen report reviewing the 457 rulemakings the Trump administration has listed as withdrawn says that FDA, with 26 withdrawn regulations, had the most of any HHS agency. Five of the 26 were designated as “economically significant,” expected to have an economic impact of at least $100 million.
Drugs
FDA has released a draft guidance on “Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.” The document is mandated by the 21st Century Cures Act, which requires FDA to revise “Section V. Demonstrating Insignificant Risk of an
Drugs
FDA says it is including patent submission dates in the Orange Book prospectively. FDA began patent submission date data collection in 2013 and the latest Orange Book contains patent submission dates since then, according to attorneys Sara Koblitz and Kurt Karst (Hyman, Phelps & McNamara) in a FDA Law Blog
Drugs
Federal Register notice: FDA has made available a guidance entitled “Pediatric Information for X-ray Imaging Device Premarket Notifications.” The document encourages the inclusion of pediatric indications for use for x-ray 510(k) submissions, and it provides recommendations on information to support such indications. Both new devices and modifications