Drugs
A new CDER drug safety report has outlined ongoing research priorities to improve drug safety. For example, one priority is to use electronic health care data to better determine suicide risks associated with approved drug products. “CDER must enhance its ability to determine if suicide is a potential adverse event
Drugs
FDA has denied a Haner & Kuo (New York) citizen petition, which was filed on behalf of an unnamed client, that asked FDA for immediate enforcement action against unapproved potassium chloride oral solution drug products being marketed by Pharmaceutical Associates. Like several others still pending at the agency, this petition
Drugs
CDER director Janet Woodcock is “unfit to serve as CDER director,” Public Citizen Health Research Group director Michael Carome says in a Huffington Post blog posting. Her decision last month to approve Sarepta’s Duchenne muscular dystrophy drug eteplirsen while overruling several agency experts, “represents a dangerous, unparalled capitulation to
Drugs
Jazz Pharmaceuticals has begun a rolling NDA submission for Vyxeos (cytarabine and daunorubicin liposome injection), an investigational agent for treating acute myeloid leukemia (AML). The company expects to complete the submission of the NDA by early next year, and will request a priority review. Vyxeos was granted breakthrough therapy designation
Drugs
Par Pharmaceutical has filed a lawsuit in DC federal court against FDA seeking reversal of an agency decision that revoked Par’s eligibility for 180-day exclusivity for a generic copy of Takeda’s gout drug Colcrys (colchicine) tablets. On 9/28, the agency informed Par for the first time
Drugs
The Securities and Exchange Commission (SEC) has charged the former senior director of regulatory affairs for Puma Biotechnology with insider trading based on clinical trial data to which he was privy. The SEC alleges that Robert Gadimian gained more than $1.1 million in illicit profits by secretly purchasing Puma
Drugs
FDA has released an International Conference on Harmonization guidance on “Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients (APIs).” The document is intended to “help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess,” the agency says. It defines the term
Drugs
FDA has granted AbbVie a breakthrough therapy designation for its investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) for treating patients with chronic hepatitis C virus (HCV) who failed previous therapy with direct-acting antivirals in genotype 1, including therapy with an NS5A inhibitor or protease inhibitor.
Drugs
Lehigh Valley Technologies has petitioned FDA asking it to take enforcement action against Virtus Pharmaceuticals Holdings and to remove its unapproved drug products, mislabeled dietary supplements and medical foods from the market until Virtus complies with all regulatory requirements, including submitting data to FDA to demonstrate that the products pose
Drugs
FDA is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The products are distributed by CVS and Hyland’s, and sold in retail stores and online. The agency is analyzing adverse events associated with the products, including seizures in infants and children
Drugs
FDA has placed a clinical hold on an Alcobra Ltd. clinical trial called MEASURE that is evaluating its investigational drug MDX (metadoxine) extended release for treating adult patients with attention deficit hyperactivity disorder. Alcobra says it has has not yet received written notice of the clinical hold from the agency,
Drugs
Pharmaceutical Research and Manufacturers of America says in a comment letter on an FDA draft guidance on quality metrics technical conformance that it commends the agency’s innovative vision to harness its new authorities under the FDA Safety and Innovation Act to use quality metrics reporting in risk-based scheduling
Drugs
An analysis published in the BMJ shows that of 55 unique FDA hematology-oncology medical reviewers from 2001 to 2010, 26 left agency employment and 15 of them (57.7%) later worked or consulted for the biopharmaceutical industry. The study authors from Oregon Science and Health University say they are
Drugs
Three members of the Senate Judiciary Committee — Chuck Grassley (R-IA), Richard Blumenthal (D-CT), and Amy Klobuchar (D-MN) — are asking the Department of Justice to investigate whether Mylan Pharmaceuticals violated the law when it apparently misclassified its EpiPen for the Medicaid drug product rebate program. In a 9/
Drugs
China’s State Food and Drug Administration (SFDA) says that more than 80% of clinical data from clinical trials in that country are “fabricated.” Radio Free Asia (RFA) reports that Chinese state media say that a one-year SFDA study found “breach of duty by supervision departments and malpractice by
Drugs
FDA and Athersys have reached agreement on a special protocol assessment for the design and planned analysis of a Phase 3 clinical trial involving the company’s MultiStem cell therapy product for treating ischemic stroke. The agreement applies to the protocol design, clinical endpoints, planned conduct and statistical analyses, which
Drugs
CDER says it is conducting a nationwide search for the permanent position of Office of Translational Sciences (OTS) deputy director for science. Current deputy Jan Johannessen is retiring soon. The deputy handles OTS science matters and administration of science and research programs, as well as influencing the formulation of basic
Drugs
DePuy Synthes has recalled its Small Battery Drive and Small Battery Drive II Adaptor and Light Adaptor, which are used in the company’s surgical tool systems, due to a potential explosion risk. An FDA recall notice says the battery drives have the potential to produce “extreme internal pressure, which
Drugs
FDA has placed a clinical hold on a CEL-SCI Corp. Multikine (leukocyte interleukin injection) Phase 3 clinical trial in advanced primary head and neck cancer. “Pursuant to this communication from FDA, patients currently receiving study treatments can continue to receive treatment, and patients already enrolled in the study will
Drugs
FDA has sent Pain Therapeutics a third complete response letter (CRL) on its NDA resubmission for Remoxy ER (oxycodone capsules), asking for “additional actions and data” before considering approval again. The letter focuses on the drug’s abuse-deterrent properties and proposed drug labeling, according to the company, adding that
Drugs
A 4/18-4/22 FDA inspection at Cheng Fong Chemical Co., Taoyuan City, China, found significant deviations from current good manufacturing practice for active pharmaceutical ingredients (API). A 9/15 Warning Letter says the deviations included: * failing to have an adequate maintenance procedure to prevent contamination or carry-over
Drugs
A 1/5-2/2 FDA inspection of Elite Laboratories, Northvale, NJ, found serious violations of the Postmarketing Adverse Drug Experience (PADE) reporting requirements, according to a just-released 9/25 Warning Letter from the agency’s New Jersey District Office. Specifically, the letter says, the firm failed to develop