Devices
CDRH says that it will take into consideration an assessment of patients’ tolerance for risk when deciding whether to take a regulatory action that could remove a medically necessary medical device from the market. This was explained during a 7/11 webinar (see transcript) on a draft guidance on Factors
FDA Policy/General
FDA says it is investigating reports of hair loss, hair breakage, balding, itching, and rash associated with the use of WEN by Chaz Dean hair cleansing conditioner products. So far, the agency has received 127 adverse event reports from consumers and it discovered more than 21,000 complaints reported directly
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on the collection of information related to certain regulations that provide protection for human subjects of clinical investigations conducted in support of applications or submissions to FDA for FDA-regulated products. The regulations provide protection of the rights, safety, and welfare of
FDA Policy/General
Federal Register Notice: FDA will hold a public workshop 10/6-7 entitled “Pre-Clinical Evaluation of Red Blood Cells for Transfusion.” Its purpose is to discuss new methodologies for pre-clinical evaluation of the safety and efficacy of red blood cell transfusion products. The workshop has been planned in
FDA Policy/General
Federal Register Notice: FDA is holding a public meeting 8/15 to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years 2018 through 2022. The meeting will be held from 9 a.m. to 2 p.m. at the FDA White Oak
FDA Policy/General
Federal Register Notice: FDA is correcting a Web link in a 6/16 Federal Register notice announcing a “Pediatric Clinical Investigator Training” workshop. To view this notice, click here.
Drugs
FDA has issued Elite Pharmaceuticals a complete response letter (CRL) on its NDA for SequestOx (oxycodone hydrochloride and naltrexone hydrochloride), an investigational abuse-deterrent opioid candidate for managing moderate to severe acute pain where the use of an opioid analgesic is appropriate. The company says that FDA determined the NDA
Drugs
Ziopharm Oncology says a patient has died in an ongoing multicenter Phase 1 study involving gene therapy candidate Ad-RTS-hIL-12 plus orally administered veledimex in recurrent or progressive glioblastoma or grade 3 malignant glioma. “The patient death resulting from intracranial hemorrhage in the third cohort of this Phase
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Bar Code Label Requirement for Human Drug Products and Blood,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available two guidances for industry entitled E2C(R2) Periodic Benefit-Risk Evaluation (E2C(R2) guidance) and E2C(R2) Periodic Benefit-Risk Evaluation Report — Questions and Answers (E2C(R2) Q&A guidance). These guidances were prepared under the auspices of the International Council for
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. GenPak Solutions, LLC Hilliard, OH (7/12). Inspected 8/3, 4, and 5/2015 and 8/7, 8/12/15. GMP deviations, adulterated, misbranded, unapproved new drug: The inspection
Drugs
FDA has placed two Lima & Pergher Brazilian drug manufacturing facilities on import alert, barring their products from entering the U.S. after an inspection detected significant GMP violations. The affected facilities are Lima & Pergher Industria, Comercio e Representacoes at 740 Airton Borges Da Silva Ave., Minas Gerais, and
Drugs
Despite a push by the White House to advance personalized medicine, this “new era of medicine” is many years away if it is ever to be truly realized, according to an article in the 7/19 MIT Technology Review. Research editor Mike Orcutt says the reasons for such pessimism are
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information “CLIA Waiver Applications,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA will hold a public workshop 10/27-28: “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers.” The workshop will discuss the current regulatory environment for these activities, the definitions of the various terms FDA proposed
Drugs
FDA says it will take 33% longer to review orphan drug designation requests due to the growing demand in new submissions. Previously, the agency worked within an internal goal to review 75% of designation requests within 90 days. Now, because of the sustained increase in designation requests over the past
Drugs
PharmaTech LLC (Davie, FL) is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium stool-softening solution distributed by Rugby Laboratories, Livonia, MI. The agency has confirmed the product has been contaminated with Burkholderia cepacia, a bacterium linked to infection outbreaks in five states. Symptoms include pneumonia,
Devices
Allergan has filed a de novo application for the Oculeve Intranasal Tear Neurostimulator device, a handheld stimulator for temporarily increasing tear production in patients with dry eye disease due to decreased tear production. The company recently announced that two pivotal trials involving the device each met their effectiveness endpoints. The
Devices
FDA has approved a Medtronic PMA for the Prestige LP Cervical Disc for treating cervical disc disease causing nerve or spinal cord compression at two adjacent levels between the neck’s C3-C7 segments. The device is designed to allow motion in the neck at the operated levels, unlike fusion
Devices
The European Union (EU) has proposed to include a medical device annex as part of ongoing negotiations under the Transatlantic Trade Investment Partnership between the U.S and the EU. The annex would encourage more harmonization on regulatory standards between CDRH and its EU counterpart. According to an EU proposal,
Drugs
FDA has posted a revised International Council on Harmonization (ICH) guidance entitled “E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)” that defines the recommended format and content of such reports and offers points to be considered in preparing and submitting them. The guidance revises, combines, and replaces two ICH guidances
FDA Policy/General
BIOLOGICS FDA has approved a Pfizer BLA supplement for Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) for an expanded age indication to include adults 18 through 49 years of age for active immunization for preventing pneumonia and invasive disease caused by 13 Streptococcus pneumoniae serotypes (1, 3,