FDA Policy/General
Federal Register notice: FDA has announced a 1/10/2018 Bone, Reproductive and Urologic Drugs Advisory Committee meeting. Panel members will discuss a Lipocine Inc. NDA for oral testosterone undecanoate capsules, seeking an indication for testosterone replacement in males for conditions associated with a deficiency or absence of endogenous testosterone:
FDA Policy/General
Federal Register notice: FDA has announced that an initial decision of the administrative law judge (ALJ) is now the final agency decision on refusing approval of a supplemental NDA for Mepergan Fortis capsules (meperidine HCl, promethazine HCl). The ALJ found that the product had not been shown to be supported
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Best Practices for Convening a GRAS Panel.” The document covers agency recommendations for convening a generally recognized as safe (GRAS) panel of experts to independently evaluate whether available scientific data, information, and methods establish that the substance is safe
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” The document discusses changes in policies and procedures surrounding the user fee assessment and collection for biosimilar manufacturers. To view the notice, click here.
FDA Policy/General
The National Antimicrobial Resistance Monitoring System (NARMS) annual report for 2015 says that while overall resistance remains low for most human infections and there have been measurable improvements in resistance levels in some important areas, the system is “closely monitoring a few areas of concern.” An agency news release says
FDA Policy/General
FDA commissioner Scott Gottlieb says an FDA Hiring Initiative will reimagine the agency’s hiring practices and procedures with the goal of attracting, recruiting, and hiring and retaining professionals who support FDA’s mission. Writing in an FDA Voice blog post, Gottlieb says a comprehensive evaluation of hiring practices and
FDA Policy/General
FDA direct-to-consumer ad researchers say their content analysis of 50 television direct-to-consumer (DTC) prescription drug ads airing between 7/2012 and 8/2014 suggests an unintended consequence of a focus on risk completeness without an accompanying focus on understandability. The study analysis is reported in the
FDA Policy/General
Federal Register notice: FDA has classified the automated indirect immunofluorescence microscope and software-assisted system into Class 2 (special controls). The classification is in response to a 2014 de novo classification request from Inova Diagnostics for its NOVA View Automated Fluorescence Microscope. The agency is codifying the classification by adding
FDA Policy/General
Federal Register notice: FDA has classified the prostatic artery embolization device into Class 2 (special controls). The action was in response to a 2016 BioSphere Medical de novo classification request for the Embosphere Microspheres. The agency has codified the classification by adding 21 CFR 876.5550 and naming the generic
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Lupin Ltd. Mumbai, India (11/6): FDA inspected the firm’s Goa and Indore drug manufacturing facilities in April and May and documented significant GMP violations with finished pharmaceuticals.
FDA Policy/General
Comments Sought on Condom Labeling Info Collection Federal Register notice: FDA seeks comments on an information collection for “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms — 21 CFR 884.5300.” 11/09/2017 Upcoming Blood Products Advisory Committee Meeting Federal Register notice: FDA announces an 11/
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection for “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms — 21 CFR 884.5300.” The document provides recommended labeling intended to provide important information for condom users, including the extent of protection provided by condoms against
FDA Policy/General
Federal Register notice: FDA has announced an 11/30 to 12/1 Blood Products Advisory Committee advisory committee meeting. Panel members will meet in an open session to discuss bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion.
FDA Policy/General
Federal Register notice. FDA has announced the availability of a draft guidance for industry on “Use of a Drug Master File for Shared System REMS Submissions.” The document provides information to applicants who are part of a shared REMS system on using an electronic Type V Drug Master File. To
FDA Policy/General
Bloomberg News reports that former Eli Lilly executive Alex Azar is expected to be named HHS secretary, replacing former Rep. Tom Price, who resigned after his extensive use of private and military jets at taxpayer expense was documented. Bloomberg cautioned that President Donald Trump is in the midst of an
FDA Policy/General
Federal Register notice: CDER is seeking comments on a proposed “Analysis Data Reviewer’s Guide” (ADRG) template that was developed under an ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), an independent, non-profit consortium addressing computational science issues. The template is under review to determine whether the Center
Drugs
The Better Business Bureau’s National Advertising Division (NAD) has referred advertising claims made by Synergy Pharmaceuticals to the Federal Trade Commission after the drug company declined to participate in a NAD proceeding. NAD says the Synergy claims for its Trulance (plecanatide) chronic idiopathic constipation prescription drug made in online
FDA Policy/General
Federal Register notice: FDA has made available a guidance on “Recurrent Herpes Labialis (RHL): Developing Drugs for Treatment and Prevention.” The document is intended to assist sponsors in all development phases of development and it also addresses prevention of RHL. It outlines the types of nonclinical studies and clinical trials
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a new proposed information collection supporting its “Draft Guidance for Industry and Review Staff on Target Product Profile — A Strategic Development Process Tool.” Target product profiles (TPPs) can be prepared by a sponsor and then shared voluntarily with the appropriate FDA review
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision for its “Guidance for Industry on Expedited Programs for Serious Conditions — Drugs and Biologics OMB Control Number 0910 – 0765.” The guidance provides a single resource for information on FDA’s policies and procedures related to the following expedited
FDA Policy/General
Federal Register notice: FDA has classified genetic health risk assessment systems into Class 2 (special controls). The action was taken in response to a 2016 de novo request submitted by 23andMe for its Personal Genome Service Test. To view the notice, click here.
FDA Policy/General
Federal Register proposed order: FDA is proposing to reclassify the needle destruction device, renaming the device to “sharps needle destruction device,” from Class 3 into Class 2 (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the agency believes are necessary to provide a