Drugs
An new study in the Pharmacotherapy journal by CDER drug safety officials and academic researchers suggests that FDA’s move to a consumer-friendly adverse event reporting form has “contributed positively to both the quality and quantity of consumer reports.” The move to the consumer voluntary reporting form (ConVR) occurred
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Abbreviated New Animal Drug Applications — Section 512(b)(2) and (n)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and (n)(1))” (OMB Control Number 0910-0669). To view
Drugs
Dalhousie University Health Law Institute director Matthew Herder says that so far FDA’s power to withdraw approval of a drug if its manufacturer fails to produce useful post-approval required clinical studies on time is an “empty threat.” Herder interviewed senior FDA officials involved in the approval of Sarepta’
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.” The document discusses uncertainty as part of the agency's overarching approach to a benefit-risk based framework
Drugs
A 2/4-2/8 FDA inspection at Polimeros y Servicios, San Jose, Costa Rica, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other issues. An 8/22 Warning Letter says the violations were: * failing to have, for each batch of drug product, appropriate
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Balamurali K. Ambati, Eugene, OR (8/13): FDA inspected the clinical investigator in April and cited Ambati for not adhering to applicable statutory requirements governing the conduct of clinical
Drugs
The drug industry has dropped to the bottom of the Gallup Poll’s annual Work and Education Poll, taking that position away from the federal government in terms of its net-positive score. Pharma received a 27% total positive ranking, 15% neutral, and 58% total negative, for a -31 net
Drugs
Under terms of a consent decree entered by a Tennessee federal judge, Basic Reset and Biogenyx must stop distributing drugs, dietary supplements, and medical devices until they comply with the Federal Food, Drug, and Cosmetic Act and other requirements in the decree. According to a Justice Department complaint filed with
Biologics
A 3/4-3/8 FDA inspection at Stemell, Inc., San Juan Capistrano, CA, found current good manufacturing practice (CGMP) and current good tissue practice (CGTP) violations in the firm’s manufacturing of products derived from human umbilical cord blood and umbilical cord for allogenic use. An 8/28 Warning
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for patent extension purposes for Millennium Pharmaceuticals’ Bevyxxa (betrixaban maleate), indicated for the prophylaxis of venous thromboembolism in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility
Drugs
CDER deputy center director for clinical science Robert Temple says the agency and drug industry are in the third age of drug development — the age of individualization. Speaking last month at a precision dosing workshop at the agency’s Silver Spring, MD headquarters, Temple noted that the previous ages covered
Devices
Federal Register notice: FDA is extending the comment period for an 8/2 notice on a draft guidance entitled “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.” Comments can now be submitted until 10/31. To view the notice, click here.
Drugs
An FDA 3/18-3/22 inspection at Yino, Inc., Chongqing, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). An 8/12 Warning Letter says the deviations were: * failing to transfer all quality or regulatory information received from the API manufacturer to
Drugs
FDA has released a summary of seven updates made to the REMS (Risk Evaluation and Mitigation Strategy) Web site during July and August. The document has information on a shared system REMS released 7/1, two withdrawn NDAs, and changes to four REMS.
Drugs
CDRH Seeks to Fill Vacancies on Device Panels Federal Register notice: FDA requests nominations for voting members to serve on CDRH’s Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee panels. 08/30/2019 Docket No. on Pediatric Rare Disease Corrected Federal Register notice: FDA corrects
FDA Policy/General
Turing Pharmaceuticals says it has begun dosing the first group of subjects in a single ascending dose study, to evaluate the safety, tolerability and pharmacokinetics of an oral formulation of TUR-004 in healthy young adult subjects. The company says the study is aimed at obtaining approval for treating epileptic
FDA Policy/General
BIOLOGICS FDA has approved Sandoz’s Zarxio (filgrastim-sndz), a copy of Amgen’s Neupogen (filgrastim), indicated for patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; patients undergoing autologous peripheral blood progenitor cell collection and
Drugs
Novartis says that later this year it will file a BLA and seek other global approvals for its leukemia drug Arzerra (ofatumumab) and its use in treating relapsing forms of multiple sclerosis (MS). The submission will be based on just-announced data from the Phase III ASCLEPIOS I and II
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members to serve on CDRH’s Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee panels. Nominations should be made before 10/29 to be giveen first consideration for membership on the panels. There are 48 current or
FDA Policy/General
Federal Register notice: FDA has corrected the docket number in a 12/2017 notice entitled “Pediatric Rare Diseases--A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance.” Docket number “FDA-2017-N-6476” has been corrected to read “FDA-2017-D-2991.” To view the
FDA Policy/General
Federal Register notice: FDA is seeking comments on nine bulk drug substances that the agency has considered and is proposing not to include on its list of bulk drug substances (or active pharmaceutical ingredients) that outsourcing facilities may use in drug compounding. The nine bulk drug substances are: dipyridamole, ephedrine
Devices
FDA has granted Concept Medical a “breakthrough device designation” for MagicTouch AVF, a sirolimus drug-coated balloon (DCB) catheter for percutaneous transluminal angioplasty treatment of stenotic lesions related to arteriovenous (AV) fistulae or AV arteriovenous grafts in patients undergoing hemodialysis treatment due to renal failure. The company says “preliminary data