Drugs
FDA has denied on two procedural grounds a Virtus Pharmaceuticals 7/11 petition that presented information alleging that Lehigh Valley Technologies, Pharma Research Software Solutions (PRSS), and Pharma-Med, Inc. inappropriately avoided paying user fees for two NDAs. The petition asked the agency to: * institute proceedings to remove the relevant
Drugs
A new nationally representative poll of more than 1,000 adults by Consumer Reports (CR) reveals that most Americans (84%) do not want companies to be allowed to advertise drugs for a use that has not been approved by FDA. The survey results (XXINSERT LINKXX) were shared at the second
Drugs
Yale University’s Collaboration for Research Integrity and Transparency renews its sharp criticism of the pending 21st Century Cures Act as “a disaster still,” despite changes, for its likely weakening effects on FDA regulation of medical products. Despite some changes since it was introduced, the pending 21st Century Cures Act
Drugs
Senate majority leader Mitch McConnell (R-KY) has reiterated that he is “redoubling” his push to see the 21st Century Cures Act, legislation to accelerate the cycle of discovering, developing, and delivering new cures and treatments to patients, signed into law this year. “There are two priorities for me for
Drugs
FDA has removed a partial clinical hold on a Adaptimmune Therapeutics planned study of its NY‑ESO SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell therapy in myxoid round cell liposarcoma (MRCLS). The hold was issued in August as part of the agency’s request for additional chemistry, manufacturing and
Drugs
FDA has released the FDA-483 from a 9/14-10/14 Dallas District Office inspection at Cantrell Drug Co., an outsourcing facility, showing 12 violations. Specific inspection observations were: * aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
Drugs
FDA has approved Bristol-Myers Squibb’s Opdivo (nivolumab) for treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy. Approval was based on data from a randomized trial (CheckMate 141) comparing nivolumab with chemotherapy
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says that as a first step in dealing with off-label information dissemination, FDA should create a clear safe harbor for manufacturer communications concerning new medicines and off-label uses of approved medicines with payers and other population health decision makers, “a highly
Drugs
[Report by John Hope] Congressional observers see the possibility that a lame duck session of Congress opening 11/14 will fast-track approval of the 21st Century Cures legislation that has made its way in companion bills through both the House and Senate. With Republican control of both the House
Drugs
Sen. Chuck Grassley (R-IA) has asked the HHS inspector general to provide records on the 2009 identification of EpiPen’s misclassification that he says led to significant overcharging of taxpayers. Grassley also invited the inspector general to testify at an 11/30 Judiciary Committee hearing on the misclassification and
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) describing the review process for INDs and NDAs for botanical drug products and the role of the Center’s Botanical Review Team in the Office of Pharmaceutical Quality’s Immediate Office. The document says the policies and procedures “are intended
Drugs
Consumers visiting branded prescription drug Web sites may misinterpret information learned from clicking on disease awareness Web sites shown on the drug site. That’s the conclusion of a study reported in the Journal of Health Communications that was conducted by CDER staff and other researchers. The researchers found that
Drugs
FDA has accepted an Emmaus Life Sciences NDA for its orally administered pharmaceutical grade L-glutamine treatment for sickle cell disease. The submission is based on data from a Phase 3 study that demonstrated a reduction in the frequency of sickle cell crises and hospitalizations, as well as a reduction
Drugs
Two Forbes commentators say that FDA’s current “all-or-nothing” system for approving drugs hurts patients and should be replaced with a system of partial approvals. University of Chicago economist Tomas Philipson and University of Southern California pharmacy and public policy professor Darius Lakdawalla write that patients are hurt
Drugs
FDA has hired former Merck executive Peter Stein to serve as CDER Office of New Drugs (OND) deputy director effective 11/14. As OND deputy, Stein will work to set guidance and policy to ensure an efficient drug development and review process, which includes maintaining effective communications with regulated industry
Drugs
Three Hyman, Phelps & McNamara attorneys — Kurt Karst, John Fleder, and Robert Dormer — say that the current FDA “non-system” of announcing major drug approval decisions when the agency wants to do so, with no advance notice to potential litigants, courts, or the public regarding when the decision will be
Drugs
Yale Law School professors Jeanie Kim and Amy Kapczynski urge FDA not to back down on its opposition to off-label marketing of drugs. Writing in JAMA Internal Medicine, the two say that the current approach to off-label marketing “has protected the public and helped provide physicians with rigorous
Drugs
FDA has placed a clinical hold on a BioInvent International Phase 2 study of the antibody BI-505 in patients with multiple myeloma. The agency told the company that the hold was placed due to an adverse cardiopulmonary event in the clinical study, which is being conducted at the University
Drugs
FDA is publishing a final rule, which takes effect 1/9/17, that establishes new regulations for citizen petitions, petitions for stays of action, and the submission of documents to the agency to implement provisions of the FDA Amendments Act of 2007 and the FDA Safety and Innovation Act that
Drugs
A 4/13-4/17/15 FDA inspection at Innovative Compounding Pharmacy, Folsom, CA, found that the pharmacy was not receiving valid prescriptions for individually-identified patients for a portion of the drug products it produced, was producing domperidone drug products that were not the subject of an appropriate monograph
Drugs
FDA is considering industry and advertiser proposals to allow links to risk information in promotional activities on character space-limited social media platforms like Twitter. It has announced new studies being designing to address the question of whether substantive risk information on such platforms is effective in communicating risks when
Drugs
FDA has posted a guidance on “Non-Inferiority Clinical Trials to Establish Effectiveness” that discusses the appropriate use of such study designs to provide evidence on the effectiveness of a drug or biologic. The document says that a non-inferiority design is usually used because a superiority study design (drug