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)
Devices
FDA will publish in the 1/17 Federal Register a notice proposing to implement regulations on internal agency supervisory review of certain decisions related to medical devices regulated by CDRH to conform to applicable provisions of the FDA Safety and Innovation Act and the 21st Century Cures Act. The notice
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
FDA Policy/General
Regulatory Review Period Determined for Uromedica’s Proact Federal Register notice: FDA determines that the regulatory review period for Uromedica’s Proact Adjustable Continence Therapy For Men was 3,892 days. 01/12/2018 Comments Extended for Guide on Submitting ANDA/505(b)(2) Federal Register notice: FDA reopens the
FDA Policy/General
FDA Webview’s newsroom will be closed Monday (1/15) in observance of Martin Luther King day. Nightly emails will resume 1/16.
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
FDA Policy/General
Federal Register notice: FDA has determined that the regulatory review period for Uromedica’s Proact Adjustable Continence Therapy For Men was 3,892 days. Of this time, 3,179 days occurred during the testing phase and 713 days occurred during the approval phase. The device is indicated for treating adult
FDA Policy/General
Federal Register notice: FDA has reopened the comment period until 2/12 on a draft guidance on “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” The document is intended to assist applicants in determining which one of the abbreviated approval pathways is appropriate for submitting a
FDA Policy/General
Federal Register notice: FDA has extended the comment period on a draft guidance entitled “Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.” Submit either electronic or written comments by 2/18. To view the notice, click here.
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
Devices
FDA has released a guidance on “Unique Device Identification (UDI): Policy Regarding Compliance Dates for Class I and Unclassified Devices.” The agency’s UDI system is designed to identify devices though distribution and use. System requirements are being phased in over seven years according to established compliance dates based primarily
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,
Biologics
FDA has approved a GlaxoSmithKline supplemental BLA for an expanded indication for Fluarix Quadrivalent (influenza vaccine) to include use in those six months and older. Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses and type B viruses, in those three years of
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,
FDA Policy/General
Federal Register notice: FDA has announced a 2/14-15 Anesthetic and Analgesic Drug Products Advisory Committee meeting. Panel members are scheduled to review a Pacira Pharmaceuticals supplemental NDA for Exparel (bupivacaine liposomal injectable suspension), indicated to produce local analgesia and as a nerve block to produce regional analgesia. To
FDA Policy/General
Federal Register notice: FDA has requested OMB clearance for an information collection extension for “Certification To Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674) OMB Control Number 0910-0616.” The certification is intended to affirm that all applicable requirements for submitted information to the national clinical
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
FDA Policy/General
FDA has released its 2018 Strategic Policy Roadmap that identifies four priority areas to be the focus of additional policy activity in 2018—reducing the burden of addiction crises that are threatening American families; leveraging innovation and competition to improve healthcare, broaden access, and advance public health goals; empowering consumers
Devices
FDA is giving healthcare providers information about reports of pneumothorax events associated with feeding tube placement procedures using enteral access systems. A MedWatch notice says most reports indicate the pulmonary events required urgent intervention, including needle decompression or chest tube placement. Several of the events were associated with cardiopulmonary arrest