Devices
FDA has granted a de novo clearance for Sciex Diagnostics’ LC MS-based Vitamin D 200M Assay for use on the company’s Topaz System. “The CDC has established a Vitamin D Standardization-Certification Program (VDSCP) and the SCIEX Topaz Vitamin D 200M Assay Kit has successfully met the rigorous
Drugs
FDA has accepted a Bristol-Myers Squibb supplemental BLA that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma (HCC) after prior sorafenib therapy. The agency has granted the submission a priority review and previously granted Opdivo orphan-drug designation for treating HCC. The user fee
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension on “Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile — OMB Control Number 0910–0614.” The notice solicits input on the information collection requirements related to the exceptions or alternatives to labeling requirements
Biologics
CBER Office of Compliance and Biologics Quality has cited the unnamed owner of a Web site (http://www.americanpumpkins.com) for promoting its In Home Blood Test for HIV 1 and 2 and the Oral In Home Saliva Test for HIV 1 and 2. A just-posted agency letter says
FDA Policy/General
FDA 5/23 alerted veterinarians and dog owners to a risk of accidental overdose in administering Sileo (dexmedetomidin), an oral prescription gel marketed by Parsippany, NJ-based Zoetis for canine noise aversion. According to an FDA news release, Sileo is packaged in a dosing syringe with a ring-stop mechanism
Drugs
A Foundation for Research on Equal Opportunity white paper, “The Competition Prescription: A Market-Based Plan for Making Innovative Medicines Affordable,” says that increasing competition among drug companies is the surest way to lower drug prices. “Drug prices continue to grow at rates exceeding inflation and economic growth due to
Drugs
Writing in his first FDA Voice blog post as commissioner, Scott Gottlieb says his “highest initial priority is to take immediate steps to reduce the scope of the epidemic of opioid addiction.” He writes that he e-mailed his agency colleagues to tell them of the first steps he plans
FDA Policy/General
The Trump Administration’s just-released budget request is proposing to increase user fee collections in fiscal year (FY) 2018 by $1.306 billion (68%) over current FY 2017 levels to $3.223 billion. For example, prescription drug fees would jump by $508 million in 2018 — increasing by 67% from
Devices
FDA has released the FDA-483 issued at the completion of an 11/29-12/16/16 agency inspection at Repro-Med Systems, Chester, NY. Inspection observations were: * failing to report in writing to FDA a correction or removal conducted to reduce a health risk posed by a medical device;
Drugs
A 2/13-2/17 FDA inspection at Changzho Jintan Qianyao Pharmaceutical Raw Materials Factory, Changzhou City, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API), according to a 5/11 Warning Letter. Specific deviations noted in the letter were: * failing to implement
Drugs
The Supreme Court has declined to hear an appeal filed by Jack and Peter DeCoster over their three-month prison sentences under the Park doctrine’s responsible corporate officer provisions. The jail term had been upheld by a 2-1 8th Circuit Court of Appeals decision, attorney Jennifer Thomas (Hyman,
EIRs/483s
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Changzhou Jintan Qianyao Pharmaceutical Raw Material Factory, Changzhou City, China (5/11):FDA inspected the firm in February and documented significant GMP deviations associated with its active pharmaceutical ingredients.
Drugs
Stakeholders are commending FDA for a draft guidance on considerations in demonstrating interchangeability with a reference product and recommending additional items to be included in the document. Pharmaceutical Research and Manufacturers of America (PhRMA) says the guidance “provides welcome insights into FDA’s current thinking” and would benefit from several
Drugs
FDA has granted Merck accelerated approval for Keytruda (pembrolizumab) for treating patients whose cancers have a specific genetic feature (biomarker). “This is the first time the agency has approved a cancer treatment based on a common biomarker rather than the location in the body where the tumor originated,” an FDA
Drugs
FDA medical reviewers say the “totality of analytical data support the determination that Epoetin Hospira is highly similar to U.S.-licensed Epogen/Procrit notwithstanding minor differences in clinically inactive components.” That conclusion is included in a briefing document prepared for the 5/25 meeting of the Oncologic Drugs Advisory
Devices
FDA says the Abbott-Thoratec 3/29 recall of its HeartMate II LVAS pocket system controller is Class 1. The device was recalled due to risk of patient injury and/or death during backup controller exchange, an agency notice says. The controller is a power supply that connects to an
FDA Policy/General
Federal Register notice: FDA seeks comments on an information collection extension for its “Guidance for Industry — User Fee Waivers, Reductions, and Refunds for Drug and Biological Products—OMB Control Number 0910–0693.” The notice solicits comments on recommendations to applicants considering whether to request a waiver or reduction in user
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension related to “Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-Market Periodic Safety Reports in the International Conference on Harmonization E2C (R2) Format.” The guidance is intended to promote a consistent approach
FDA Policy/General
Federal Register notice: FDA has announced a 6/20 Endocrinologic and Metabolic Drugs Advisory Committee meeting. The panel is scheduled to discuss a supplemental NDA for Novo Nordisk’s Victoza (liraglutide) injection for a proposed additional indication as an adjunct to standard treatment of cardiovascular risk factors to reduce the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension on “Prescription Drug Advertisements; OMB Control Number 0910–0686.” The agency’s information collection requires that manufacturers who advertise prescription human and animal drugs, including biological products for humans, disclose in advertisements certain information about the advertised product’
Drugs
A 5/24 FDA Oncologic Drugs Advisory Committee plans to discuss agency concerns over “uncertainty in the magnitude of treatment effect due to unplanned” and multiple amendments to the clinical trial protocol involving Puma Biotech’s Nerlynx (neratinib) and its proposed indication for the extended adjuvant treatment of adult patients
Drugs
FDA is warning drug manufacturers of non-sterile, water-based drug products that there have been the subject of recent product recalls due to Burkholderia cepacia complex (BCC) contamination. “BCC and other water-borne opportunistic pathogens are among the contaminants that can be found in pharmaceutical water systems,” an agency