Drugs
The LIGHT trial to determine whether the combination of naltrexone and bupropion increases major adverse cardiovascular events was terminated early after an unplanned release of confidential interim data by the sponsor (Orexigen) and the results “remain uncertain and will require evaluation in a new adequately powered outcome trial,” according to
FDA Policy/General
FDA says it is proposing to research the use of superimposed text in direct-to-consumer DTC) drug ads. A Federal Register notice says that the proposed study is intended to extend previous research on the effects of such text in general print and TV advertising to today’s modern
Drugs
The CDER Office of Generic Drugs has issued a Manual of Policies and Procedures (MAPP) on scoring configuration of generic drug products. The document says that consistent scoring assures that patients are able to adjust the drug’s dose by breaking a generic drug in the same manner as the
Biologics
FDA has issued a guidance, Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271, to give establishments that manufacture human cells, tissues, and cellular and
Drugs
The Tufts Center for the Study of Drug Development says that immuno/oncology (I/O) research aimed at treating at least 28 types of tumors “is taking alliances between pharma, biotech companies, and universities and cancer centers to new heights.” The latest Tufts Impact Report (subscription or purchase required) says
Devices
FDA has cleared a Life Spine 510(k) for the Prolift Expandable Interbody System for use in spinal disorder surgeries. The all-titanium device is designed to restore disc height, in-situ, during posterior lumbar interbody fusion, transforaminal lumbar interbody fusion and oblique surgical approaches. The company says it allows
Drugs
FDA has released a draft guidance on “Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans” that addresses the agency’s current thinking on implementing requirements for such plans to be submitted under the Food Drug and Cosmetic Act’s
Drugs
A 1/12-2/13/15 FDA inspection at Chemolee Lab Corp., Irving, TX, found significant violations of current good manufacturing practice for finished pharmaceuticals and other violations, according to a 2/23 Warning Letter from the agency’s Dallas District Office. Specific violations included: failing to thoroughly investigate any
Devices
A 6/3-6/23/15 FDA inspection at Repro-Med Systems, Chester, NY found multiple violations in the firm’s work as a specification developer and manufacturer of infusion pumps and intravascular administration sets, according to a 2/26 Warning Letter from the agency’s New York District Office.
Drugs
Amgen is asking a New Jersey federal court to rule that Sandoz cannot skip biosimilar “patent dance” negotiations over its Neulasta (pegfilgrastim). Big Molecule Watch reports online that Amgen told the court that (1) in 11/2015, Sandoz notified Amgen that FDA had accepted Sandoz’ pegfilgrastim aBLA and provided files
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Chemolee Lab Corp. Irving, TX (2/23). Inspected 1/12/15-2/13/15. GMP deviations, adulterated, misbranded, unapproved new drugs: The firm failed to thoroughly investigate any unexplained
Drugs
FDA says it is launching a “lean management process mapping approach to build a better system for combination products review – one that’s more cohesive, more collaborative, and more systematic.” The process begins with an analysis of what’s being done currently, and then it designs a future process state
Drugs
Sagent has recalled one lot of fluconazole injection, USP, 200mg per 100mL to the user level due to an out of specification impurity result detected during routine quality testing of stability samples at its 18-month interval. This impurity has been identified as metronidazole, according to a recall notice, and
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes. It has been developed to assist sponsors who intend to submit an IDE to FDA to conduct clinical trials on medical devices targeting
FDA Policy/General
Federal Register Notice: FDA is making available a document entitled Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry. It provides establishments that make donor eligibility determinations for donors of human cells, tissues, and
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails. It is intended to provide recommendations on clinical trial design for medical devices intended either to provide improvement in the appearance of
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Environmental Assessment: Questions and Answers Regarding Drugs with Estrogenic, Androgenic, or Thyroid Activity. It is intended to help sponsors of such drugs determine whether they should submit environmental assessments (EA) for drug applications and certain supplements, and to
FDA Policy/General
Federal Register Notice: FDA is making available a revised guidance for industry entitled A Dietary Supplement Labeling Guide: Chapter II. Identity Statement. It is part of a longer guidance entitled A Dietary Supplement Labeling Guide, which covers the most frequently raised questions about the labeling of dietary supplements using a
FDA Policy/General
Federal Register Notice: FDA will hold a public workshop 5/19 entitled “Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation.” The purpose of the workshop is to share current FDA experiences on the application of mechanism-based absorption modeling and simulation in regulatory activities; discuss current
FDA Policy/General
Federal Register Notice: FDA’s Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee will meet 4/20, from 8 a.m. to 6 p.m. at the Hilton Washington, DC/North, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD. The committee will discuss, make
FDA Policy/General
Federal Register Final rule: FDA is removing regulations that required sponsors to submit data on the subtherapeutic use of certain antibiotic, nitrofuran, and sulfonamide drugs administered in animal feed as these regulations have been determined to be obsolete. FDA has other strategies for assessing the safety of antimicrobial new animal
Devices
FDA has approved a Sensimed de novo marketing application for the Triggerfish, a single-use contact lens that may help practitioners identify the best time of day to measure a patient’s intraocular pressure (IOP). Elevated IOP can be associated with glaucoma-related optic nerve damage. The silicone contact lens