Drugs
FDA has released the FDA-483s issued following inspections at Aurobindo Pharma Units 5 and 8. The inspection at Unit 5 in Telangana, India, ran from 10/21-10/28 and resulted in four inspection observations: * laboratory controls do not always include the establishment of scientifically sound and appropriate procedures
Drugs
As part of the Project Orbis collaboration with the Australian Therapeutic Goods Administration and Health Canada, FDA has granted supplemental approval to AstraZeneca’s Calquence (acalabrutinib) for treating adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. An agency statement says Project Orbis provides a framework for concurrent submission and
Drugs
Washington Legal Foundation (WLF) is urging the U.S. Court of Appeals for the DC Circuit to affirm a decision blocking an HHS rule that would require drug makers to include the wholesale acquisition cost (defined by HHS as the “list price”) of any drug advertised in direct-to-consumer
Drugs
A new report by the National Academy of Sciences recommends that regulators like FDA “need to make increased use of reliance and cooperation with other trusted regulators, as no regulator has the resources it needs to meet all of its public health responsibilities.” The report also said “(i)mpediments to
Drugs
An analysis commissioned by Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Innovation Organization, and the Council of State Bioscience Associations, warns that H.R. 3, House Democrats’ drug pricing plan, “could result in 56 fewer new medicines over 10 years.” The analysis projects that the bill would cut
Drugs
The World Health Organization (WHO) has released for comment a draft guideline, Guideline on Data Integrity, with information, guidance, and recommendations to facilitate compliance with data integrity and good practices in documentation and record-keeping requirements. The document does not cover medical devices. The WHO says that where possible, the
Drugs
FDA has issued a draft guidance, Transdermal and Topical Delivery Systems—Product Development and Quality Considerations, with recommendations for applicants and manufacturers of transdermal and topical delivery systems regarding the pharmaceutical development and quality information to include in NDAs and ANDAs. The document specifically discusses the agency’s current thinking
Drugs
Apicore Pharmaceutical Private is asking FDA to require that any ANDA or ANDA supplement for penicillamine capsules be approved only if the bioequivalence study supporting such approval uses a bioanalytical method that stabilizes penicillamine from oxidation as soon as the blood samples are collected and measures copper-bound penicillamine, along
Drugs
In a recent CDER Webinar, Office of Prescription Drug Promotion lead project manager Jason Cober reviewed various types of errors the agency is seeing in promotional submissions in eCTD (electronic common technical document) format. A final guidance on eCTD submission of promotional labeling and advertising materials was issued 6/24.
Drugs
A 4/15-4/30 FDA inspection at Apothecus Pharmaceutical, Hicksville, NY, found significant violations of current good manufacturing practice (CGMP) regulations for combination products. Specific violations listed in an 11/8 Warning Letter were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of
Drugs
A 3/11-4/9 FDA inspection at Torrent Pharma, Levittown, PA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/28 Warning Letter says specific violations were: * failing to use equipment in the manufacture, processing, packing, or holding of drug products that is
Drugs
Reps. David Cicilline (D-RI) and Jerrold Nadler (D-NY) have introduced the Affordable Prescriptions for Patients Through Promoting Competition Act (H.R. 5133) to use the Federal Trade Commission (FTC) to prohibit drug companies from engaging in anticompetitive “product hopping.” Text of the bill is not yet available. In
Drugs
The Center for Science in the Public Interest (CSPI) says FDA should send Warning Letters to companies marketing 39 dietary supplements that explicitly or implicitly claim to treat female infertility because they are being marketed as unapproved and/or misbranded drugs. In an 11/18 letter, CSPI says the products’
Drugs
Bristol-Myers Squibb and Celgene say they will divest Celgene’s psoriasis drug Otezla to Amgen for $13.4 million to settle Federal Trade Commission (FTC) charges that Bristol-Myers Squibb’s proposed $74 billion acquisition of Celgene would violate federal antitrust law. The commission has said that, as proposed,
Drugs
FDA has sent Nascent Biotech an untitled letter objecting to promotional content on the company’s Web site about its investigational drug pritumumab. The letter says that discussing the drug’s safety and effectiveness for the purpose for which it is being investigated misbrands the product. FDA says the Web
Drugs
FDA has issued a final guidance entitled “Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.” The document is intended to serve as a focus for continued discussions among the Division of Antiviral Products, pharmaceutical sponsors, the academic community, and the public. It focuses on drugs that are expected
Drugs
FDA has granted Levo Therapeutics a fast track designation for LV-101 (intranasal carbetocin) for treating Prader-Willi syndrome (PWS). Levo is currently enrolling patients in a Phase 3 clinical study (CARE-PWS) of intranasal carbetocin for the indication. The study has an eight-week period designed to test the
Drugs
Generic drug companies have had mixed results from FDA efforts to help them get timely samples from brand-name companies for bioequivalence testing, according to a new Government Accountability Office (GAO) report. One on the most notable delays occurs with brand products where FDA has required risk evaluation and mitigation
Drugs
FDA’s Endocrinologic and Metabolic Diseases Advisory Committee has voted 16 to 0 to recommend approval for Amarin’s submission to expand Vascepa’s (icosapent ethyl) indication to reduce the risk of cardiovascular events as an adjunct to statin therapy in adults with elevated triglycerides and other cardiovascular disease risk
Drugs
FDA has approved a Novartis BLA for Adakveo (crizanlizumab-tmca) for reducing the frequency of vaso-occlusive crisis — a sickle cell disease-related common and painful complication that occurs when blood circulation is obstructed by sickled red blood cells. “Adakveo is the first targeted therapy approved for sickle cell disease,
Drugs
FDA has approved a Shionogi & Co. NDA for Fetroja (cefiderocol), an antibacterial drug for treating patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options. Approval is based on
Drugs
FDA has issued a final guidance entitled “Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention” to assist drug manufacturers designing studies to evaluate safety and efficacy of such drugs. The agency notes that smallpox was declared eradicated in 1980, but “concerns exist that it could remain in unknown