FDA Policy/General
FDA says it is posting computer code and a technical roadmap to allow researchers and developers to customize and use the agency’s new MyStudies app. An online notice says the app is designed to facilitate input of real-world data directly by patients that can be linked to electronic
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products.” The document describes the factors FDA intends to consider when evaluating the strength of evidence provided by a meta-analysis studying the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a revised information collection on “Postmarketing Adverse Drug and Biological Product Experience Reporting and Recordkeeping” (OMB Control Number 0910-0230). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Hypertension: Developing Fixed-Combination Drug Products for Treatment.” The document focuses on development of two-drug combinations of previously approved drug products. It incorporates comments received for and finalizes a 1/26 draft guidance. To view the notice, click
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision for “Tropical Disease Priority Review Vouchers” (OMB Control Number 0910-0822). The agency has developed the guidance document to explain how it will implement the program, and how sponsors may use priority review vouchers and how vouchers may
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Vital Rx dba Atlantic Pharmacy and Compounding Pompano Beach, FL (9/26): FDA inspected the firm in July and cited serious deficiencies
FDA Policy/General
Federal Register notice. FDA is seeking comments on an information collection extension for its “Guidance for Industry on Individual Patient Expanded Access Applications: Form FDA 3926” (OMB Control Number 0910-0814). Individual patient expanded access allows an individual patient who has a serious or immediately life-threatening disease or condition
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking.” The document describes FDA’s intention to defer enforcement of unique device identification requirements for Class I and unclassified devices, other
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Biosimilars User Fee Program” (OMB Control Number 0910-0718). The Biosimilar User Fee Act of 2012 authorized FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development. It was reauthorized
FDA Policy/General
Novanta has acquired privately-held Zettlex Holdings and its inductive encoders that can provide absolute and accurate positioning even in extreme operating environments. Novanta says there is a growing demand for precision motion technology in robotics, precision automation and key medical markets. Janssen Biotech has agreed to purchase HC2 Holdings
FDA Policy/General
Draft Guide on Hepatitis B Drugs Federal Register notice: FDA makes available a draft guidance entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.” 11/02/2018 Workshop on Hemophilia Product Development Federal Register notice: FDA announces a 12/6 public workshop entitled “Product Development in Hemophilia.” 11/02/
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment.” The document includes general considerations for nonclinical toxicology and virology studies, early phase clinical development, clinical pharmacology assessments, and Phase 3 safety and efficacy trials. It also discusses Phase 3
FDA Policy/General
Federal Register notice: FDA has announced a 12/6 public workshop entitled “Product Development in Hemophilia.” The workshop is intended to advance further development of patient- experience and patient-reported outcomes for use in clinical trials, facilitate reliable and interpretable measurements of Factor VIII/IX activity levels for gene therapy
FDA Policy/General
Federal Register notice: FDA has classified the meprobamate test system into Class 2 (special controls). The action follows a 2/2017 de novo classification request from Lin-Zhi International for its LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay. The device is identified as being intended to measure meprobamate in human specimens.
FDA Policy/General
Federal Register notice: FDA has classified insulin therapy adjustment devices into Class 2 (special controls). The action follows a DreaMed Diabetes de novo classification request for its DreaMed Advisor Pro. Such devices are identified as intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to
FDA Policy/General
Federal Register notice: FDA is withdrawing two proposed medical device rules after determining that they are not currently considered viable candidates for final action. The withdrawal is part of the agency’s regulatory reform process. The two proposed rules that are being pulled are: a proposed amendment to the performance
FDA Policy/General
FDA has told the House Energy and Commerce Committee that the number of Office of Criminal Investigations (OCI) special agents assigned to Port of Entry (POE) duty doubled in August from six to 12. In addition, OCI added an import senior operations manager to oversee the program, and also added
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Bar Code Label Requirement for Human Drug and Biological Products” (OMB Control Number 0910-0537). In 2004, FDA issued a final rule that requires human drug product and biological product labels to have bar codes. Specifically, the
FDA Policy/General
Federal Register notice: FDA has announced a 12/4-5 meeting of the Science Advisory Board to the National Center for Toxicological Research (NCTR). On 12/4, the NCTR director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. On 12/5, there will
FDA Policy/General
A Vanda Pharmaceuticals Web page for Fanapt (iloperidone) tablets for oral use and Hetlioz (tasimelteon) capsules for oral use presents information about the two drugs but fails to include any risk information about either one, according to a 10/22 Warning Letter issued by CDER’s Office of Prescription Drug
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Considerations for the Development of Dried Plasma Products Intended for Transfusion.” The document provides recommendations on optimal sources of input plasma; manufacturing and product quality, including product characterization; packaging and reconstitution; clinical studies; and device submissions. To view the
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of 10 NDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested each approval be withdrawn. To view the notice, click here.