Drugs
FDA has denied a Mayne Pharma 11/22/16 petition asking that the agency require specific in vitro dissolution criteria as part of the bioequivalence demonstration for any ANDA citing Doryx MPC (doxycycline delayed-release tablets), EQ 60 mg base and EQ 120 mg base as the reference-listed drug
Biologics
FDA commissioner Scott Gottlieb says the agency is working on about a dozen new policies to help the fledgling biosimilar market grow and gain acceptance. “We are going to be advancing new policies to try to stimulate more biosimilar development,” Gottlieb said during a 3/28 keynote address at CNBC’
Drugs
FDA is calling on the United States Pharmacopeia (USP) to withdraw a proposed revision to the General Notices and Requirements relating to USP drug product monographs for biological products. In a comment letter, the agency says it is “concerned that efforts to develop biological product monographs could impede or delay
Drugs
FDA has published the annual report on information related to inspections of facilities necessary for approval of a drug or medical device required by the 2017 FDA Reauthorization Act. The report shows that: * median time between inspection request from FDA staff reviewing a drug application or report to the beginning
Drugs
Federal Register notice: FDA has submitted for OMB approval an information collection extension for “Premarket Notification for a New Dietary Ingredient — 21 CFR 190.6” (OMB Control Number 0910–0330). The information collection supports agency regulations and guidance documents that requests information upon which the manufacturer or distributor has based
Drugs
A Florida federal judge has approved a consent decree of permanent injunction sought by FDA against MyNicNaxs, Deltona, FL, and company owner Chevonne Torres and officer Michael Banner. The agency says the company distributed weight loss and sexual enhancement products, marketed as dietary supplements, directly to consumers through two Web
Devices
CDRH reviewed in a 3/20 Webinar contents of two updated guidances that implement provisions of the 21st Century Cures Act — the acceptance and filing a review for PMA applications guidance and the refuse-to-accept policy for 510(k) guidance. CDRH Office of Device Evaluation policy analyst James Bertram
FDA Policy/General
Federal Register Final Rule; technical amendment: FDA has amended its regulations to reflect an organizational change for CDER’s Office of Regulatory Policy. FDA is taking this action to ensure accuracy and clarity in its regulations. To view the notice, click here.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Biotek Inc. Layton, UT (3/13): FDA inspected the firm 8/2017 and cited it over product claims that cause its dietary supplements to be unapproved drugs. For example,
Drugs
Attorneys Erika Maley and Jacquelyn Fradette (Sidley Austin) say that courts and litigants should be very aware of the potential preemption and jurisdiction issues raised by state suits against opioid manufacturers alleging inadequate warnings. Writing in a Washington Legal Foundation Legal Backgrounder, the two say that state tort suits’ claims
Drugs
A 5/15-5/17/17 FDA inspection at Clover Custom Blending, Tampa, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 2/28 Warning Letter. Specific violations cited in the letter were: * failing to thoroughly investigate any unexplained discrepancy or failure
Drugs
A 5/25-5/31/17 FDA inspection at Keshava Organics, Maharashtra, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients. A 3/15 Warning Letter says the specific deviations were: * failing to adequately investigate out-of-specification results and to implement appropriate corrective actions;
Devices
FDA has cleared a Canon Medical Systems USA 510(k) for a suite of quantitative tools to assess the spectrum of liver disease (including steatosis, inflammation and cirrhosis) on the company’s Aplio i800 ultrasound system. In addition to Shear Wave Elastography imaging, the new suite adds Attenuation Imaging and
FDA Policy/General
Federal Register notice: FDA is requesting nominations for members to serve on its Pharmacy Compounding Advisory Committee, which provides advice on scientific, technical, and medical issues concerning human drug compounding. Nominations received on or before 5/29 will be given first consideration for membership on the committee. To view the
Drugs
A recent inspection of a Cipla drug manufacturing plant in Goa, India has documented significant GMP violations. According to a just-posted Form 483 from a 1/22-25 inspection, the firm failed to thoroughly review out-of specification results and in-process test failures. The inspection also revealed that
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Elemental Impurities in Animal Drug Products — Questions and Answers.” The document is intended to assist sponsors in addressing changes in United States Pharmacopeia requirements for controlling elemental impurities in drug products. It includes recommendations on all dosage forms and
FDA Policy/General
Federal Register notice: FDA has amended a public workshop entitled ‘‘Orthopedic Sensing, Measuring, and Advanced Reporting Technology (SMART) Devices’’ to reflect a change in the start and end times. The public workshop is now scheduled for 4/30, from 8 am to 5:30 pm. To view the notice, click
Drugs
Delaware federal court judge Richard Andrews has granted a Shire motion to dismiss a 2/7/17 Federal Trade Commission (FTC) complaint alleging that the company abused the FDA citizen petition process to prevent generic competition to its Vancocin. FTC said Shire “inundated” FDA with 46 regulatory and court filings
Devices
The Justice Department says Alere will pay the federal government $33.2 million to resolve allegations that it caused hospitals to submit false claims to federal healthcare programs by knowingly selling materially unreliable point-of-care diagnostic testing devices. A government False Claims Act complaint said that between 1/2006
Drugs
The Biotechnology Innovation Organization (BIO) says its members would benefit from more clarity in terms of a specific timeframe for when FDA might make a preliminary non-binding opinion on whether an application meets the criteria for priority review voucher eligibility. “We recommend that the preliminary opinion be conveyed in
Devices
FDA says it has allowed the marketing (de novo process) of the first fully interoperable continuous glucose monitoring system. Dexcom’s G6 integrated continuous glucose monitoring (iCGM) system is intended to determine blood glucose levels in children aged two and older and adults with diabetes, according to an agency news
Drugs
FDA has approved a Novo Nordisk supplemental NDA for Tresiba (insulin degludec injection) 100 U/mL, 200 U/mL to include data from the DEVOTE safety outcomes study. The following data from the study in patients with Type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) are now included in the