Devices
FDA and CMS’s parallel review program has fallen short and “failed to address the real obstacles manufacturers face in getting medical devices to patients,” a new study from George Mason University’s Mercatus Center finds. Launched in 2011 (see story), the pilot anticipated approving medical devices concurrently for both
Devices
FDA and other government agencies are hosting an 11/8 public workshop on “Promoting Semantic Interoperability of Laboratory Data” that is intended to discuss proposed approaches to facilitate the adoption and implementation of interoperability standards in a manner that enables consistent, accurate, and harmonized descriptions of in vitro diagnostic tests
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
FDA Policy/General
ANIMAL DRUGS FDA Amends Animal Drug Regs for Approvals, Etc. Federal Register Final Rule: FDA has amended the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during July and August. FDA has also made available approval summaries and environmental
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
FDA Policy/General
Federal Register Notice: FDA has announced the fee rate of $2.7 million for using a tropical disease priority review voucher for fiscal year 2017. The vouchers are awarded to sponsors of certain tropical disease product applications, submitted after 9/27/2007, upon FDA approval of such applications. To view
FDA Policy/General
Federal Register Notice: FDA has announced the fee rate of $2.7 million for using a rare pediatric disease priority review voucher for fiscal year 2017. The vouchers are awarded to sponsors of rare pediatric disease product applications that meet all of the requirements of the program and were submitted
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.
Devices
FDA has cleared a NuVasive 510(k) for its MAGEC system to be surgically implanted using its Reline posterior fixation system for treating patients with severe spinal deformity conditions. MAGEC comprises a single-use spinal rod that is surgically implanted to brace the spine and includes a small internal magnet
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
FDA Policy/General
Federal Register Final Order: FDA has classified the Evoked Photon Image Capture Device into Class 1 (general controls). The device is identified as a prescription, electrically-powered device intended for use as a non-invasive measurement tool that applies electricity to detect electrophysiological signals emanating from the skin, which are
FDA Policy/General
Federal Register Final Rule: FDA has amended the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during July and August. FDA has also made available approval summaries and environmental review documents. Additionally, the animal drug regulations have been amended
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
Devices
FDA has approved a label extension for Roche’s EGFR Mutation Test v2 for use with plasma samples as a companion diagnostic for Astra Zeneca’s Tagrisso (osimertinib), which is indicated for patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). The test
FDA Policy/General
A 9th Circuit Court of Appeals decision appears to “impermissibly grant FDA authority to regulate the practice of medicine and to further muddy the regulatory morass governing off-label use of products,” according to attorneys Anne Walsh and Andrew Hull (Hyman, Phelps & McNamara). Writing in their firm’s FDA
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,
FDA Policy/General
Federal Register Notice: FDA has announced an opportunity for public comment on information collection related to an extension of “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111.” The collection pertains to records of personnel practices, including training documentation; records of
FDA Policy/General
Federal Register Notice: FDA has corrected a 9/13 notice on the availability of a guidance on “Use of Nucleic Acid Tests To Reduce the Risk of Transmission of West Nile Virus From Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products.” The notice was corrected to
FDA Policy/General
Federal Register Notice: FDA has corrected a 9/19 notice on “Biosimilar User Fee Act; Public Meeting.” The document was published with the incorrect date of the closure of the docket, which now reads 10/28/2016. To view this notice, click here.