Drugs
FDA says that since the demand for immune globulin (IG) products has increased in recent years, despite supply increases, there is an ongoing shortage of IG intravenous and IG subcutaneous products in the U.S. that could affect patient care. An agency statement says that in the setting of increased
Drugs
FDA says Pfizer is recalling two lots of Relpax (eletriptan hydrobromide) 40 mg tablets due to potential microbiological contamination of non-sterile products. An agency statement says the company initiated the recall because the lots may not meet its in-house microbiological specification for the potential presence of Genus pseudomonas
Drugs
FDA says it will be making changes to its inactive ingredient database (IID) that provides information on inactive ingredients present in FDA-approved drugs. The information can be used by industry as an aid in developing new drugs, an agency notice says. The notice says FDA will use a phased
Drugs
The New York Times editorial board says that while the goal of getting new medicines to desperate patients as quickly as possible is a worthy one, the uncertainty surrounding expedited drugs has strained the public’s trust and made it easy for insurance companies to deny coverage for such drugs.
Drugs
FDA has added three additional questions and answers to the laboratory control section of the questions and answers on current good manufacturing practices guidance. The added questions and answers cover instrument calibration standards for chromatographic systems, system suitability, and trial injections. The agency says that it is essential that analytical
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it generally supports an FDA draft guidance on quality considerations for continuous manufacturing and believes the document could benefit from greater clarity on some key concepts. The association’s comment letter also says the guidance’s language could be enhanced to better
Drugs
FDA has approved the Global Alliance for TB Drug Development’s Pretomanid tablets to be used in combination with bedaquiline and linezolid to treat a limited and specific population of adult patients with extensively drug resistant, treatment-intolerant, or non-responsive multidrug resistant pulmonary tuberculosis. An agency statement says that
Drugs
FDA has issued Dr. Reddy’s Laboratories two complete response letters for generic copies of Teva’s multiple sclerosis drug Copaxone (glatiramer acetate injection) and Merck’s female contraceptive Nuvaring (etonogestrel/ethinyl estradiol) vaginal ring. Dr. Reddy’s declined to disclose the reasons for the FDA rejection letter, but said
Drugs
Federal Register notice of intent: FDA has announced its intention to begin inactivating drug listing records that are improperly listed in accordance with FDA requirements because these drug listings are not certified as being active and up to date or are associated with a manufacturing establishment that is not currently
Drugs
House Committee on Oversight and Reform chairman Elijah Cummings (D-MD) and Senate Budget Committee ranking member Bernie Sanders (I-VT) have written to three drug companies asking about their pricing of generic drugs and opening an investigation into what Cummings and Sanders say is the companies’ coordinated obstruction of
Drugs
The FDA Oncology Center of Excellence (OCE) and Syapse have signed a multi-year research collaboration agreement focusing on using real-world evidence (RWE) to support regulatory decision making. Syapse says that it and OCE “will work with stakeholders across FDA to address key regulatory questions about testing and treatment
Drugs
FDA has revised a 2015 draft guidance on “Gastroparesis: Clinical Evaluation of Drugs for Treatment.” The agency says new changes reflect its current thinking on developing clinical outcome assessment measures and statistical considerations for using those measures to assess primary and secondary efficacy endpoints of clinical trials for gastroparesis. The
Drugs
Drug recalls decreased 18.1% to 77 in the second quarter of 2019, tied for the second lowest number over the past 10 quarters, according to the Stericycle Quarter 2 recall index. However, the report says that recalled units increased 86.3% to just under 24 million, almost double the
Drugs
FDA says it will begin inactivating drug listing records that are improperly listed in accordance with agency requirements because the drug listings are not certified as being active and up to date or are associated with a manufacturing establishment that is not currently registered with FDA. A Federal Register notice
Drugs
A 2/11-2/20 FDA inspection at Emcure Pharmaceuticals, Maharashtra, India, found a significant violation of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 8/2 Warning Letter says the specific violation was: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any
Drugs
FDA says its review of additional data found no increased risk of prostate cancer with the use of entacapone (Orion’s Comtan and Stalevo) to treat Parkinson’s disease. An 8/13 drug safety communication, updating a 3/31/10 communication, says the agency’s recommendations for using Comtan (entacapone)
Drugs
Dalhousie University researcher Matthew Herder says that since FDA gradually shifted to a model of lifecycle regulation in the 1990s, it is not simply an agency in transition but rather an agency on guard against a set of larger political threats to its mandate. Writing in Milbank Quarterly, Herder says
Drugs
FDA has issued a final guidance, Child-Resistant Packaging Statements in Drug Product Labeling, to assist applicants, manufacturers, packagers, and distributors who choose to include child-resistant packaging statements in their drug product labeling. The document discusses what information should be included to support child-resistant packaging statements in labeling
Drugs
Attorney Kellie Combs (Ropes & Gray) says that while FDA wants to work with industry on incorporating elements of real-world evidence (RWE) in drug development programs, many in industry have said it’s not likely that industry will start to conduct a lot of RWE studies until there is
Drugs
A group of U.S. Senate Democrats is urging FDA acting commissioner Ned Sharpless to heavily punish AveXis for submitting “manipulated” data (see story) with recently approved Zlogensma, a gene therapy product intended to treat children less than two years old with spinal muscular atrophy. The agency says it was
Drugs
Federal Register notice: FDA has extended the comment period on a 7/9 notice about a public meeting entitled “Incorporating Alternative Approaches in Clinical Investigations for New Animal Drugs; Public Meeting; Request for Comments.” Comments are now being accepted until 9/16. To view the notice, click here.
Drugs
FDA has granted Dare Bioscience a qualified infectious disease product designation for its novel thermosetting hydrogel-containing clindamycin phosphate 2% and its use for treating bacterial vaginosis in women. The company says its thermosetting hydrogel formulation can result in better antibiotic delivery to the vaginal infection, which can lead to