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
Devices
FDA says four reagent kits manufactured and distributed by Carolina Liquid Chemistries Corp., Winston Salem, NC, are adulterated and misbranded. A just-released 7/31 Warning Letter says the firm does not have a 510(k) or PMA for the kits. The letter says the firm distributes the kits with
FDA Policy/General
Federal Register notice: FDA has announced a 12/5 public meeting entitled “2019 Public Meeting on CDER Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program.” The meeting is intended to help ensure that the clinical outcome assessments (COAs) and endpoints developed reflect what is most important to patients
FDA Policy/General
FDA has issued a draft guidance, Compounding Animal Drugs from Bulk Drug Substances, to describe agency policy on the compounding of animal drugs from bulk drug substances by or under the direct supervision of veterinarians or licensed pharmacists. The document says FDA has generally exercised enforcement discretion with regard to
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. A.P. Deauville, New Brunswick, NJ (11/8): FDA inspected the firm in April and cited significant GMP violations for finished pharmaceuticals. For example, it failed to thoroughly investigate
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,
Devices
CDRH Office of Product Evaluation and Quality technical guidance specialist Jason Ryans says the purpose of the new safety and performance-based pathway is to establish a voluntary more modern 510(k) pathway for demonstrating safety and effectiveness for certain well-understood devices. Speaking during a CDRH 11/7 Webinar,
Biologics
FDA has accepted for review a Samsung Bioepis BLA for SB8, a biosimilar candidate referencing Genentech’s Avastin (bevacizumab). Avastin is indicated for treating five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma;
Devices
An FDA device safety update about intra-aortic balloon pumps by Getinge’s Maquet/Datascope shutting down while running on battery power says the agency has received dozens more reports since an 11/2018 alert was issued. The malfunction can lead to the pumps’ stoppage and loss of hemodynamic support,
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
FDA Policy/General
Federal Register notice: FDA has withdrawn ANDA approvals for two fentanyl transdermal systems held by Mayne Pharma Group and Actavis Laboratories. The drug products are both transdermal systems designed with a liquid reservoir. The companies have both requested withdrawal of their respective applications and have waived their opportunity for a
Devices
FDA’s Immunology Devices Panel of the Medical Devices Advisory Committee last week recommended that FDA should require dentists to move away from using mercury-containing amalgams and towards non-mercury containing products like composite materials when conducting dental restoration procedures. The panel agreed that FDA’s latest literature review
Devices
FDA has approved a Cerapedics PMA supplement for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion procedures in patients with degenerative cervical disc disease. Cerapedics’ submission requested approval for an updated package insert that incorporates the 24-month follow-up data from subjects enrolled in the
Devices
CDRH has established a “Patient and Caregiver Connection” program to obtain feedback from these stakeholders on their experiences living with a condition or using medical devices. Certain partner organizations collect feedback on specific issues from their members and share that feedback with CDRH. “This patient feedback on the impact of
Devices
FDA has approved CooperVision’s MiSight, the first contact lens indicated to slow the progression of myopia (nearsightedness) in children between the ages of eight and 12 years old. The single use, disposable, soft contact lens is intended to be discarded at the end of each day, and is not
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
Biologics
FDA has hit a milestone with the approval of Pfizer’s Abrilada (adalimumab - afzb), a biosimilar to AbbVie’s Humira, which is the 25th biosimilar product approved since 2010 when Congress gave the agency authority to approve biologic product knockoffs. Abrilada is indicated for treating rheumatoid arthritis, juvenile idiopathic arthritis,
FDA Policy/General
Proposal to Withdraw 4 NDAs Federal Register notice: FDA proposes to withdraw approval of four NDAs from multiple NDA holders because they have repeatedly failed to file required annual reports. 11/15/2019 OTC Drugs Panel Charter Renewal Federal Register notice: FDA announces the renewal of the Nonprescription Drugs Advisory