Drugs
Three Hyman, Phelps & McNamara attorneys — Kurt Karst, John Fleder, and Robert Dormer — say that the current FDA “non-system” of announcing major drug approval decisions when the agency wants to do so, with no advance notice to potential litigants, courts, or the public regarding when the decision will be
Drugs
Yale Law School professors Jeanie Kim and Amy Kapczynski urge FDA not to back down on its opposition to off-label marketing of drugs. Writing in JAMA Internal Medicine, the two say that the current approach to off-label marketing “has protected the public and helped provide physicians with rigorous
Devices
Johnson & Johnson says it commends FDA for creating a comprehensive and thoughtful draft guidance on when a 510(k) is necessary when implementing changes to a previously cleared 510(k) device containing software. “We particularly appreciate the collaborative approach that FDA demonstrated during the development of this document,” it
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Innovative Compounding Pharmacy Folsom, CA (6/20). FDA investigators conducted a 4/2015 inspection after receiving an adverse event reportedly experienced by a patient who received a domperidone product
FDA Policy/General
Federal Register Final Rule: FDA has issued a final rule to amend the regulations to reflect organization change in the agency and to make other conforming changes. This action is editorial in nature and is intended to improve the accuracy of the agency’s regulations. To view the notice, click
FDA Policy/General
Federal Register Notice: FDA has established a public docket to collect comments related to a proposed Study Data Standardization Plan template. The template was developed by a working group under an ongoing collaboration with the Pharmaceutical Users Software Exchange, an independent, non-profit consortium addressing computational science issues. The template
Drugs
FDA has placed a clinical hold on a BioInvent International Phase 2 study of the antibody BI-505 in patients with multiple myeloma. The agency told the company that the hold was placed due to an adverse cardiopulmonary event in the clinical study, which is being conducted at the University
Devices
An 8/23-9/1 FDA inspection at Valeant Pharmaceuticals’ Rochester, NY, facility found Quality System Regulation violations in the firm’s work as a specification developer and distributor of the Small Particle Size Aerosol Generator, a nebulizer pneumatic flow system for administering Virazole ( ribavirin) aerosol and the OraPharma ONSET
Drugs
FDA is publishing a final rule, which takes effect 1/9/17, that establishes new regulations for citizen petitions, petitions for stays of action, and the submission of documents to the agency to implement provisions of the FDA Amendments Act of 2007 and the FDA Safety and Innovation Act that
Drugs
A 4/13-4/17/15 FDA inspection at Innovative Compounding Pharmacy, Folsom, CA, found that the pharmacy was not receiving valid prescriptions for individually-identified patients for a portion of the drug products it produced, was producing domperidone drug products that were not the subject of an appropriate monograph
Drugs
FDA is considering industry and advertiser proposals to allow links to risk information in promotional activities on character space-limited social media platforms like Twitter. It has announced new studies being designing to address the question of whether substantive risk information on such platforms is effective in communicating risks when
FDA Policy/General
Federal Register Notice: FDA is asking for comments on an OMB submission seeking an information collection extension on using focus groups about drug products. The agency says focus groups serve a narrowly defined need for direct and informal opinion on a specific topic and as a qualitative research tool. It
FDA Policy/General
Federal Register Notice: FDA has established a public docket to receive input on a new CDRH program on “Patient and Care-partner Connection.” Under the program, CDRH will partner with patient organizations to provide a means for Center staff to formally engage with patients and care-partners to gain perspective
FDA Policy/General
Federal Register Notice: FDA has made available a guidance on “Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes.” The document is intended to assist sponsors who intend to submit an IDE to conduct clinical trials on medical devices targeting neurological disease progression
Drugs
FDA has posted a guidance on “Non-Inferiority Clinical Trials to Establish Effectiveness” that discusses the appropriate use of such study designs to provide evidence on the effectiveness of a drug or biologic. The document says that a non-inferiority design is usually used because a superiority study design (drug
Devices
FDA has cleared an EOS Imaging 510(k) to market the kneeEOS software, an online 3D planning product that uses weight-bearing 3D images and data from the EOS system to provide an optimized surgical plan for total knee arthroplasty. “The software makes an initial automatic proposal for the size
Drugs
FDA has approved an Amgen supplemental BLA for the expanded use of Enbrel (etanercept) to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque psoriasis. Approval is based on data from a Phase 3 one-year study and its five-year open-label extension study. “In addition
FDA Policy/General
FDA commissioner Robert Califf and CMS administrator Andrew Slavitt offer their perspectives on the two agencies’ changing approaches and evidence standards for admitting products to the market and Medicare paying for them. Writing in a new JAMA viewpoint article, the two say that “changes in the organization of health care
Devices
FDA has released a final guidance on “Medical Device Reporting (MDR) for Manufacturers” that is intended to help companies meet applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions. The document covers MDR requirements to develop, maintain, and implement written procedures for identifying and evaluating all
FDA Policy/General
ANIMAL DRUGS Guide on Animal Drug User Fees/Waivers Federal Register Notice: FDA has made available a draft revised guidance on “Animal Drug User Fees and Fee Waivers and Reductions.” The document describes the types of fees FDA is authorized to collect under the Animal Drug User Fee Act of
Drugs
FDA has granted AbbVie an Orphan Drug Designation for veliparib, an oral poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor, being investigated in combination with chemotherapy or radiation for treating advanced squamous non-small cell lung cancer. The company describes PARP as a naturally-occurring enzyme in the body that repairs
Devices
FDA has cleared two Medicrea Group 510(k)s for its PASSXS posterior fixation and LigaPASSXS band connector components designed to address pediatric spinal deformities in small stature patients. The company says it has worked with a team of leading pediatric spinal surgeons to develop low-profile implants specially tailored