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Federal Register notice: FDA is extending the comment period for an 8/2 notice on a draft guidance entitled “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.”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 The document has information on a shared system REMS released 7/1, two withdrawn NDAs, and changes to four REMS.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
Drugs
FDA has granted Akari Therapeutics an orphan drug designation for nomacopan and its use in treating hematopoietic stem cell transplantation-associated thrombotic microangiopathy (HSCT-TMA). Orphan status follows a fast track designation given earlier this month for the same indication in pediatric patients. The company says it is planning a
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for patent extension purposes for Puma Bio’s Nerlynx (neratinib), indicated for extended adjuvant treatment of adult patients with early stage HER2- overexpressed/amplified breast cancer. The review period was 5,102 days, which includes 4,738 days that occurred
FDA Policy/General
FDA acting commissioner Ned Sharpless may be on the out as President Trump has not nominated him to be the permanent agency head, and under the Federal Vacancies Reform Act of 1998 he can only serve in a Senate-confirmed position for a maximum of 210 days, which would give
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) posted 8/12 an on-demand Webinar discussing elements of the 6/24 final guidance on providing promotional labeling and advertising materials in electronic and non-electronic format. OPDP lead project manager Jason Cober discussed the 24-month transition period for promotional
FDA Policy/General
Federal Register notice: FDA has extended the submission period related to a 6/29 notice on “Modernizing Pharmaceutical Quality Systems; Studying Quality Metrics and Quality Culture; Quality Metrics Feedback Program.” Submissions are now being accepted until 12/30. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Placebos and Blinding in Randomized Controlled Cancer Clinical Trials for Drug and Biological Products.” The document finalizes an 8/24 draft guidance entitled “Hematologic Malignancy and Oncologic Disease: Considerations for Use of Placebos and Blinding in Randomized Controlled Clinical
Drugs
AstraZeneca says that the Phase 3 TULIP 2 trial for anifrolumab, an investigational drug for treating systemic lupus erythematosus (SLE), met its primary endpoint — “achieving a statistically-significant and clinically-meaningful reduction in disease activity versus placebo, with both arms receiving standard of care.” The reduction, it says, “was measured
Drugs
Collegium Pharmaceutical, a specialty pain management drug company, says it appreciates recent FDA actions related to the opioid crisis. In a comment on an agency draft guidance on considerations for a benefit/risk assessment framework for opioids, the company says it agrees with FDA that an assessment of opioid analgesic