Drugs
FDA already has the regulatory flexibility it needs to make drug decisions based on evidence from a variety of sources, according to former FDA commissioner Robert Califf and four other agency staffers, writing in an online Nature article that was submitted while Califf was still in office. The article says
Drugs
A bipartisan group of senators led by Michael Bennet (D-CO) and Marco Rubio (R-FL) have reintroduced the RACE for Children Act (Research to Accelerate Cures and Equity for Children Act) to support the development of innovative and promising cancer drugs for children. The bill would amend the Pediatric
Drugs
FDA has accepted for priority review an EMD Serono and Pfizer BLA for avelumab as a treatment for patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-based therapy. The agency has set a user fee review target action date of 8/27. Avelumab
Drugs
Panelists at a Harvard School of Public Health forum on “The 21st Century Cures Act: Implications for Research and Drug Development,” expressed concerns about the faster FDA drug approvals envisioned under the law. American Cancer Society chief medical officer Otis Brawley said that mere ineffectiveness is not the worst thing
Drugs
CDER officials say the Center has two initiatives intended to improve its ability to conduct benefit/risk assessments of new drugs. Writing in the International Society for Pharmacoeconomics and Outcomes Research journal, CDER director Janet Woodcock and Office of the Commissioner staffer Kathleen Miller say the initiatives include patient-focused
Drugs
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Chongqing Pharma Research Institute Co. Chongqing (2/14): FDA inspected the firm 5/2016 and cited significant GMP deviations for active pharmaceutical ingredients. For example, the firm failed to
Drugs
An AcelRx Pharmaceuticals 505(b)(2) NDA has been submitted for Dsuvia (sufentanil sublingual tablet, 30 mcg) for treating patients with moderate-to-severe acute pain in a medically supervised setting. The agency has set a user fee target review date of 10/12. The submission includes data from four
Drugs
Genentech says it supports FDA’s consolidation and move to electronically coded manufacturing establishments information. Late last year, the agency published a draft guidance, Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information, discussing the requirements and implementation of the Federal Food, Drug, and Cosmetic Act on valid
Drugs
FDA has accepted for review an Antares Pharma for QuickShot Testosterone (QST), a drug-device combination product for the delivery of testosterone enanthate using a subcutaneous auto injector, indicated for treating adult men with low testosterone associated with hypogonadism. The agency has set a user fee review target date of
Drugs
CDER has posted a revised Manual of Policies And Procedures (MaPP) on the publication and use of good review practices (GRPs) within the Center. “Review staff are expected to become thoroughly familiar with pertinent GRPs and to adhere to these GRPs when conducting their reviews unless a particular part of
Drugs
Endo Pharmaceuticals has recalled one lot of Edex (alprostadil for injection) 10 mcg 2 Pack due to a potential for lack of sterility assurance. The recall is due to the detection by Endo of a defect in the crimp caps used in the product’s manufacturing, according to a recall
Drugs
Last year, CDER’s Office of Generic Drugs (OGD) approved the highest number of ANDAs in the history of the generic drug program – more than 800 submissions (including full and tentative approvals). Last year’s performance eclipsed 2015’s previous record of 726 ANDAs. In a new blog posting, OGD
Drugs
Research should be conducted on whether an off-label use of a medical product should be disclosed to patients under informed consent, according to University of Arizona law professor and faculty member of Harvard’s Petrie Flom Center for Health Care Policy, Bioethics and Biotechnology Christopher Robertson. In a recent
Drugs
A CDER Exclusivity Board memorandum explains the reasoning the agency followed in determining the scope of three-year exclusivity for Inspirion Delivery Technologies’ Morphabond (morphine sulfate) extended-release tablets. Attorney Kurt Karst (Hyman, Phelps & McNamara) writes in his firm’s FDA Law Blog that the memo “details FDA’s
Drugs
Two Johns Hopkins University professors say that the European Medicines Agency’s (EMA) 2016 publication on its Web site of clinical study reports for carfilzomib (Amgen’s Kyprolis) and lesinurad (Ironwood’s Zurampic) puts pressure on FDA to change its long-standing position that such reports are confidential commercial information
Drugs
FDA has accepted a Novartis supplemental NDA for expanded use of Zykadia (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The submission is based on the primary
Drugs
FDA has approved an expanded indication for Celgene’s Revlimid (lenalidomide) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant. The orally administered thalidomide analogue was originally approved in 2006 for use with dexamethasone in patients with multiple myeloma who received at least one prior therapy.
Drugs
FDA 2/21 issued Dr. Reddy’s Laboratories a three-observation Form-483 after inspecting its Miryalaguda active pharmaceutical ingredients (API) plant in Telangana, India. The API plant was cited in a 2015 Warning Letter, and this presumably was a follow up inspection based on comments made late last year
Drugs
The House Energy and Commerce health subcommittee has announced a 3/2 hearing on “Examining FDA’s Generic Drug and Biosimilar User Fee Programs.” The hearing is part of the reauthorization process as both programs are set to expire 9/30. FDA and relevant stakeholders will provide testimony on how
Drugs
A group of physicians under the Mifeprex REMS Study Group are calling for FDA to withdraw a risk evaluation and mitigation strategy (REMS) program for the medical abortion drug Mifeprex because they say it no longer makes clinical sense. The distribution of Mifeprex “remains substantially and unnecessarily encumbered by a
Drugs
Spectral Medical says it plans to submit in the second quarter the last of four modules for a PMA for Toraymyxin, indicated for treating patients with endotoxemic septic shock. The therapeutic hemoperfusion device is designed to remove endotoxin, which can cause sepsis, from the bloodstream and is guided by the
Drugs
A lengthy ProPublica report shows how major drug companies have quietly used academic researchers in public relations campaigns to support the high cost of some drugs. Many of the academics are leading economists and healthcare experts at major universities who also work for Precision Health Economics, it says. The report