Drugs
A 3/27-3/31/17 FDA inspection at Delta Laboratories Pty. Ltd., Somersby, Australia, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 12/19/17 Warning Letter. Specific violations cited in the letter were: * failing to thoroughly investigate any unexplained discrepancy
Drugs
FDA says it is working with the Department of Defense (DoD) to prioritize efficient development of medical products intended to save the lives of American military personnel. A FDA announcement says the program framework comes through legislation that authorized the Defense Department to request, and FDA to provide, assistance to
Drugs
A 7/31-8/3/17 FDA inspection at Shanwei Honghui Daily Appliance Co., Ltd., Shanwei, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 12/5/17 Warning Letter. Specific violations cited in the letter were: * failing to clean, maintain, and,
Drugs
An FDA drug safety alert says Tesaro’s Varubi (rolapitant) injectable emulsion has been associated with anaphylaxis and other serious hypersensitivity reactions. The product is approved to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). The reactions have occurred during or soon after the infusion of Varubi, with most
Drugs
FDA has launched a new pilot to offer more transparency with drug approval decisions. “One place where we are evaluating how we can release information that may better inform scientists, providers, and patients is clinical study reports (CSRs),” FDA commissioner Scott Gottlieb said 1/16. A CSR is the portion
Drugs
A 5/22-5/26/17 FDA inspection at Wuhan Chinese Moxibustion Technology Dev. Co., Ltd., Wuhan, Hubei, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 12/18/17 Warning Letter. Specific violations cited in the letter were: * failing to establish
Drugs
The Government Accountability Office (GAO) says FDA should announce its plans to issue and revise product-specific guidance for drugs that are nonbiological and complex. FDA agreed with the recommendation that was included in a GAO report assessing the FDA process for reviewing generic versions of nonbiological complex drugs (NBCDs)
Drugs
Public Citizen Health Research Group director Michael Carome says those interested in providing patients additional access to unapproved medications should press Congress for legislation to further enhance FDA’s expanded access program, rather than backing “right-to-try” legislation that would undermine the program. Writing in an online Stat News
Drugs
FDA has expanded the approved use of AstraZeneca’s Lynparza (olaparib tablets) to include treating patients with certain types of breast cancer that have metastasized and whose tumors have a specific genetic mutation. The agency says it is the first PARP inhibitor approved to treat breast cancer, and it is
Drugs
A new CDER regulatory science report details the agency’s efforts to ease bioequivalence (BE) requirements for locally-acting orally inhaled and nasal drug products (OINDPs). The report emphasizes the challenges to demonstrate BE for proposed generic OINDPs since the traditional PK [pharmacokinetic] approach used for systemically acting drugs is
Drugs
FDA is delaying the effective date of portions of a final rule that would have revised the agency’s existing regulations describing the types of evidence that may be considered in determining a medical product’s intended use. Comments to FDA from stakeholders complained that the proposed changes were not
Drugs
Public Citizen is questioning FDA’s delay in banning from the market all hydroxyethyl starch (HES) intravenous (IV) solutions, a move the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended 1/12. Last year, the group petitioned the agency to remove HES IV solutions from the market,
Drugs
FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee has voted 13 to six to not recommend approved for a Lipocine NDA for Tlando, an oral testosterone product candidate for testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone (hypogonadism). This is the second
Drugs
FDA is asking the DC federal court to dismiss United Therapeutics Corp.’s (UTC) suit seeking seven years of market exclusivity for its Orenitram (oral treprostinil), indicated for treating pulmonary arterial hypertension. FDA rejected the company’s application and UTC appealed that decision to the court. In its filing in
Drugs
FDA is requiring labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children under age 18. An agency news release says the “serious risks of these medicines outweigh their potential benefits in this population.” After the safety labeling changes are made,
Drugs
Endo says a Florida U.S. attorney has subpoenaed documents and information relating to products containing oxymorphone. “The subpoena broadly requests documents including, among others, those produced in past or pending lawsuits and those relating to product safety and efficacy, overdoses, diversion, thefts, overprescribing, dependency or tolerance, withdrawal addictiveness, adverse
Drugs
A clinical trial in South African infants of an improved vaccine for tuberculosis is the subject of an investigational report in The BMJ. The report says the children’s parents committed to the trial based on information that included the statement that the trial vaccine “has been tested in animals
Drugs
Four healthcare integrity organizations (Transparency International, TranspariMed, Cochrane, and CRIT) are urging governments worldwide to ensure that patients, doctors, and scientists can access the full results of all clinical trials. The four sponsored a study that they say showed that the results of medical research are often reported partially, incorrectly,
Drugs
FDA has released the FDA-483 issued following a 11/27/17-12/22/17 inspection at Pharmedium Services, a Sugar Land, TX, drug outsourcing facility. The form lists these inspection observations: * the quality control unit lacks the responsibility and authority to reject all drug products; * the flow of components,
Drugs
The Congressional Research Service (CRS) says stakeholders have mixed views on FDA guidance and communications in implementing the Drug Quality and Security Act on drug compounding, raising issues that Congress may wish to consider. In a report, “Drug Compounding: FDA Authority and Issues for Congress,” CRS says some in Congress
Drugs
Researchers say that an initial drug safety communication on Sanofi-Aventis’ Ambien (zolpidem) issued by FDA 1/10/13 received significant social media uptake online, while a second communication on 5/14/13 showed almost no social media use. The study, reported in JMIR Public Health and Surveillance, looked at
Drugs
FDA has accepted for priority review an Ionis Pharmaceuticals NDA for inotersen, indicated for treating patients with hereditary transthyretin (TTR) amyloidosis. The agency has set a user fee review target date of 7/6. Inotersen is an antisense drug designed to reduce TTR production. In affected patients, TTR builds up