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The HHS Inspector General (IG) has withdrawn its advisory opinion approval of Caring Voice Coalition, one of the biggest patient assistance charities in the U.S. The coalition, funded almost entirely by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Federal Register notice: FDA has made available a draft guidance entitled “Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 Waiver Applications for Manufacturers of In Vitro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FDA has issued a draft guidance, Recommendations for Dual 510(k) and CLIA Waiver by Application Studies, to assist manufacturers in using the Dual 510(k) and CLIA Waiver by Application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
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
Devices
An FDA safety alert warns that dietary supplements containing biotin (vitamin B7) can cause clinically significant incorrect lab test results. The agency says it is seeing an increase in reported adverse events, including one death, related to biotin interference with lab tests. “Biotin in patient samples can cause falsely high
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
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Export of FDA-Regulated Products: Export Certificates OMB Control Number 0910-0498.” The collection is authorized by the FDA Export, Reform, and Enhancement Act of 1996 that was designed to ease restrictions on exporting unapproved pharmaceuticals, biologics,
Devices
Sen. Chuck Schumer (D-NY) has called on the Federal Trade Commission to examine direct-to-consumer home DNA kits to ensure genetic information is not sold or shared with third parties without consumers’ informed consent. Schumer 11/26 cited the increasingly popular home genetic kits (Ancestry, 23andMe and MyHeritage)
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.” The document discusses the circumstances where packages and homogenous cases of product not labeled with a product identifier shall be exempted and grandfathered from certain drug