Drugs
Paragon Consulting says that FDA is delaying implementation of its 2013 Quality Metrics Initiative that will ultimately drive significant change in the way life sciences companies monitor and evaluate operational and quality performance. In an online report, Paragon says that as a result of refinements to two draft guidances and
Drugs
FDA commissioner Scott Gottlieb assured Congress 11/30 that the timely implementation of the 21st Century Cures Act is one of the agency’s highest priorities. During a House Energy and Commerce Committee hearing on the status of the Cures Act almost one year after its enactment, Gottlieb said the
Drugs
A Pharmaceutical Research and Manufacturers of America (PhRMA) report tracing how money flows through the biopharmaceutical supply chain says that patients should benefit from cost payments that are negotiated at various points in the chain. “Drug pricing is a complex and often confusing issue, shaped by a pharmaceutical distribution and
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
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
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The HHS Inspector General (IG) has withdrawn its advisory opinion approval of Caring Voice Coalition, one of the biggest patient assistance charities in the U.S. The coalition, funded almost entirely by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
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
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
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
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
Drugs
FDA is ramping up its efforts to improve the process for developing generic copies of complex drugs, according to commissioner Scott Gottlieb. These are products that involve a complex formulation or a complex active ingredient, and include inhaled drugs and eye drops that can’t be easily measured in the
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Dae Young Foods Co. Seoul, Korea (11/20): FDA inspected the firm in March and documented significant GMP violations for finished pharmaceuticals. For example, the firm failed to visually
Drugs
A Tufts Center for the Study of Drug Development white paper says that innovative biologics manufacturing is reducing production costs while fundamentally changing how life-saving drugs are produced. The white paper is based on a 10/2015 roundtable discussion that included senior managers from biologics development companies and officials
Drugs
Regeneron Pharmaceuticals says two Phase 2 studies looking at adding investigational drug nesvacumab to the company’s already-approved Eylea (aflibercept) injection did not provide “sufficient differentiation” to move into Phase 3 development. The RUBY study examined patients with diabetic macular edema (DME) and the ONYX study evaluated patients with
Drugs
Sun Pharmaceutical Industries has recalled (Class 2) two lots of Riomet (metformin hydrochloride oral solution), 500 mg/5mL, due to Scopulariopsis brevicaulis contamination, which was discovered during sample preparation for an antimicrobial preservative effectiveness test that was being performed as part of required 12 month stability study. Riomet is indicated
Drugs
A former compliance director at Indiana compounding pharmacy Pharmakon Pharmaceuticals has pleaded guilty to introducing adulterated drugs into interstate commerce and conspiracy to defraud the U.S. by obstructing FDA functions. Caprice Bearden (Carmel, IN) pleaded guilty in southern Indiana federal court to one count of conspiracy, three misdemeanor counts