FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials.” The draft advises dietary supplement firms of FDA’s intent to exercise enforcement discretion if a firm wishes to specify the amount of a live microbial in colony forming
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.” As a general matter, high-risk and innovative moderate-risk devices will “typically need clinical evidence to show reasonable
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Nonallergic Rhinitis: Developing Drug Products for Treatment.” The document incorporates comments received on a 2/2016 draft guidance. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Allergic Rhinitis: Developing Drug Products for Treatment.” The document addresses trial designs, effectiveness, and safety for new products being developed for the treatment of seasonal allergic rhinitis and perennial allergic rhinitis. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has extended the comment period on six draft guidance documents about developing human gene therapy products that appeared in the 7/12 Federal Register. Comments are now being accepted until 12/10. To view the notice, click here.
Drugs
A new analysis commissioned by the Pharmaceutical Research and Manufacturers of America (PhRMA) shows that about one in five hospitals marks up medicine prices 700% or more. The analysis is presumably intended to deflect criticism of the pharmaceutical industry for unnecessarily raising drug prices and thus burdening U.S. health
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” (OMB Control Number 0910-0806). The guidance is intended to aid trading partners in identifying a suspect product and terminating a notification
FDA Policy/General
Federal Register notice: FDA is seeking nominations for members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee. The panel provides advice on the technical feasibility, reasonableness, and practicability of performance standards for electronic products to control the emission of radiation from such products, and may recommend
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Physiologically Based Pharmacokinetic Analyses — Format and Content.” The document outlines the recommended format and content for a sponsor or applicant to submit physiologically based pharmacokinetic analyses to FDA to support applications. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced the charter renewal for two years of its Cardiovascular and Renal Drugs Advisory Committee. Authority for the committee will now expire on 8/27/2020. To view the notice, click here.
FDA Policy/General
Info Collection on Testing FDA Communications Federal Register notice: FDA seeks comments on a new proposed information collection entitled “Generic Clearance for Quantitative Testing for the Development of FDA Communications.” 08/31/2018 Info Collection Extension of Device Labeling Federal Register notice: FDA submits to OMB an information collection extension
FDA Policy/General
American Diversified Holdings has reached an agreement to acquire Brazos Biomedical, a biomedical device development company based in Houston, TX. Brazos has a proprietary device, Auracis, in pre-clinical development to treat headache pain using transcutaneous electrical nerve stimulation technology. BioCryst Pharmaceuticals has announced a planned merger with Idera Pharmaceuticals.
FDA Policy/General
DEVICES FDA has approved a Stryker PMA for the Surpass Streamline Flow Diverter to treat unruptured large and giant wide neck intracranial aneurysms. The device is indicated for unruptured aneurysms which are more challenging due to their location and surrounding anatomy, according to the company. “The stent is designed to
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new proposed information collection entitled “Generic Clearance for Quantitative Testing for the Development of FDA Communications.” The information collection would allow FDA to use quantitative social/behavioral science data collection techniques (i.e., surveys and experimental studies) to test consumers’ reactions
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Device Labeling Regulations — 21 CFR Parts 800, 801, and 809” (OMB Control Number 0910-0485). The information collection supports FDA’s regulations that establish requirements for the label or labeling of a medical device so that
FDA Policy/General
Federal Register notice: FDA has announced a pilot meeting program to allow sponsors to discuss the use of complex innovative trial design (CID) approaches in medical product development. Meetings under the pilot program will be conducted by CDER or CBER. For each sponsor whose meeting request is granted, the agency
FDA Policy/General
Federal Register notice: FDA has reopened for 14 days the comment period on its draft guidance entitled “Development of a Shared System Risk Evaluation and Mitigation Strategy.” To view the notice, click here.
FDA Policy/General
Washington Legal Foundation litigation division senior counsel Cory Andrews says the notion of including list prices in drug direct-to-consumer ads could not survive a First Amendment challenge and is outside of FDA’s regulatory authority. Writing in a Forbes online column, Andrews challenges the proposal that was raised
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a professional sell sheet for Ascend Therapeutics’ EstroGel 0.06% (estradiol gel) makes false or misleading claims and/or representations about the drug’s efficacy. An 8/16 Notice of Violation says the sell sheet “is concerning because it falsely suggests
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: Kelley-Ross Compounding Seattle, WA (7/30): FDA inspected the firm 7/2017 and cited it for serious deficiencies in its practices
FDA Policy/General
Federal Register notice: FDA has determined that chikungunya virus disease, Lassa fever, rabies, and cryptococcal meningitis satisfy its tropical disease definition and added them to the list of designated tropical diseases whose product applications may result in priority review voucher awards. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined that Pneumocystis pneumonia does not meet statutory criteria for designation as a tropical disease for the purposes of obtaining a priority review voucher. To view the notice, click here.