FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance entitled “Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” Based on feedback from stakeholders and comments received on the initial draft guidance, the document is being revised
FDA Policy/General
Federal Register notice: FDA has announced a 2/12 Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee meeting. Panel members are expected to discuss and make recommendations about the safety and effectiveness of surgical mesh placed transvaginally in the anterior vaginal compartment to treat pelvic organ prolapse.
FDA Policy/General
Federal Register notice. FDA has issued an order debarring physician Su-Chiao Kuo for three years from providing services in any capacity to a person that has an approved or pending drug product application. The action is based on a finding that Kuo was convicted of a misdemeanor for causing
FDA Policy/General
Federal Register notice: FDA has issued an order debarring David J. Fishman for three years from providing services in any capacity to a person that has an approved or pending drug product application. The order is based on a finding that Fishman was convicted of a misdemeanor for causing the
FDA Policy/General
Comments Sought on Real World Evidence Program Federal Register notice: FDA seeks comments on a CDER/CBER framework for implementing a program to evaluate the potential use of real-world evidence in regulatory decision making. 12/07/2018 Proposed Rule on De Novo Classification Process Federal Register proposed rule: FDA
FDA Policy/General
DEVICES FDA has cleared an EnsoData 510(k) for EnsoSleep, a software-only medical device used under the supervision of clinicians to analyze physiological signals and automatically score sleep study results. EnsoSleep is intended for use for the diagnostic evaluation by physicians to assess sleep quality and as an aid
FDA Policy/General
Federal Register notice: FDA is seeking comments on a CDER/CBER framework for implementing a program to evaluate the potential use of real-world evidence in regulatory decision making. To view the notice, click here.
FDA Policy/General
Federal Register proposed rule: FDA is proposing to establish requirements for its medical device De Novo classification process. It also intends to establish procedures and criteria for de novo classification requests. The requirements seek to ensure the most appropriate classification of devices consistent with public health protection, as well as
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products.” The document includes factors for considering when broader labeling of a companion diagnostic would be appropriate. It notes that oncology companion
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.” The document provides recommendations to control the risk of bacterial contamination of room temperature
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Environmental Impact Considerations” (OMB Control Number 0910-0322). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB 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). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for InSightec’s medical device Exablate, indicated for use in the unilateral thalamotomy treatment of idiopathic essential tremor patients with medication-refractory tremor. The regulatory review period has been determined to be 2,050 days, which
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Electronic Submission of Medical Device Registration and Listing — 21 CFR Part 807, Subparts A Through D” (OMB Control Number 0910–0625). To view the notice, click here.
FDA Policy/General
The Department of Justice says that after a year-long review of the “individual accountability policy” enunciated by then-deputy attorney general Sally Yates in a 2015 memo, it is reforming the policy to provide more potential for companies to earn cooperation credit and to resolve cases more quickly. Attorney
FDA Policy/General
Barox Co. Seongnam, Republic Of Korea (11/28): FDA inspected the drug manufacturing facility in May and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish written responsibilities and procedures applicable to the quality control unit. The firm also failed to exercise strict control over
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Aspire Bariatrics’ medical device Aspire Assist, indicated for use in adults aged 22 or older with a body mass index of 35.0–55.0 kg/m2 who have failed to achieve and maintain weight
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Synergy Pharmaceuticals’ Trulance (plecanatide), indicated in adults for treating chronic idiopathic constipation. The regulatory review period has been determined to be 3,186 days, which included 2,829 days that occurred during the testing phase
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Intercept Pharmaceuticals’ Ocaliva (obeticholic acid), indicated for treating primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. The
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment.” The document identifies knowledge gaps that represent important challenges in developing such drugs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.” The document provides procedures that will promote well-managed post-CRL meetings and help ensure that such meetings are scheduled and conducted in accordance with the commitments
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “FDA Adverse Event Reports; Electronic Submissions — 21 CFR 310.305, 314.80, 314.98, 314.540, 514.80, 600.80, 1271.350, and Part 803” (OMB Control Number 0910-0645). To view the notice, click here.