FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Patient-Focused Drug Development: Collecting Comprehensive and Representative Input.” The document is the first of a series of four methodological guidances that FDA committed to develop to address how to collect and submit information from patients and caregivers for
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Humanitarian Device Exemption (HDE) Program.” The document explains the criteria FDA considers to determine if “probable benefit” has been demonstrated as part of its decision-making process regarding marketing authorization for such devices. It also incorporates recent amendments that
Biologics
CBER says that as of 10/1, it will increase the use of secure e-mail for regulatory communications in an effort to streamline and facilitate communication with sponsors and protect proprietary and company confidential information. After 10/1, the notice says, outgoing e-mail communications containing regulatory information will
Devices
FDA has cleared a LivaNova 510(k) for its MEMO 4D semi-rigid mitral annuloplasty ring. The next-generation addition to the MEMO line offers a broader range of ring sizes from 24 to 42mm allowing an additional patient population with mitral regurgitation (MR) to be treated, according to the
Devices
FDA has cleared an Optovue 510(k) for its Avanti Widefield Optical Coherence Tomography system for non-contact, quantitative measurements of the epithelial and stromal layers of the cornea (epithelial thickness mapping or ETM). The expanded clearance adds a nine-millimeter ETM scan to the previously available six-millimeter map,
FDA Policy/General
Federal Register notice: FDA has issued a proposed list of alternative or streamlined mechanisms for complying with GMP requirements for combination products. The listing is mandated by the 21st Century Cures Act. Electronic or written comments on the notice are encouraged by 9/11. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers.” The document provides answers to common questions on communicating health care economic information to this specific audience. It also provides answers to common questions about
FDA Policy/General
Federal Register notice: FDA has made available a guidance for industry entitled “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers.” The document provides information about how FDA evaluates medical product communications that present information that is not contained in the FDA-required labeling for
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Limited Population Pathway for Antibacterial and Antifungal Drugs.” The document provides information on implementing the limited population pathway provision of the 21st Century Cures Act for such products. To view the notice, click here.
Drugs
FDA has issued scPharmaceuticals a complete response letter on its 505(b)(2) NDA for Furoscix (subcutaneous furosemide) for treating edema or fluid overload in patients with heart failure. The letter indicated the need for additional human factors studies, device modifications, and potentially a clinical validation study, according to the
Drugs
FDA has approved Genentech’s Avastin (bevacizumab) for use in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin as a single agent, for treating women with advanced (stage III or IV) ovarian cancer following initial surgical resection. Approval is based on data from the pivotal Phase 3 GOG-0218
Devices
FDA has approved a Wright Medical Group PMA for Augment Bone Graft for use in hindfoot and ankle fusion. The injectable product combines recombinant human platelet-derived growth factor and a blend of Type 1 collagen and beta tri-calcium phosphate, which is designed as an alternative to autograft. The
Drugs
FDA has accepted for review a Sunovion NDA for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes) experienced by people living with Parkinson’s disease. The agency has set a user fee review action target date of 1/29/2019. The company says apomorphine sublingual film is
Drugs
Federal Register notice: FDA has made available a draft guidance entitled “Limited Population Pathway for Antibacterial and Antifungal Drugs.” The document provides information on implementing the limited population pathway provision of the 21st Century Cures Act for such products. To view the notice, click here.
Devices
FDA has cleared a Gold Standard Diagnostics 510(k) for its Borrelia burgdorferi IgG/IgM ELISA assay. The test is intended as an initial screening assay in the CDC-recommended two-step testing for evidence of antibodies against the Lyme disease bacteria. Both steps can be performed using the same
Drugs
At the 4/10 GDUFA 2 quarterly implementation meeting, industry representatives discussed challenges facing the generic drugs industry, including threats to sustainable competition and drug shortages. The industry representatives noted that drug shortages within the generic market may also occur due to the consolidation of buyers and discussed the market
Devices
FDA has told Congress that, as mandated by the 21st Century Cures Act, it has implemented mandatory training on the least burdensome requirements for medical device review staff and supervisors, conducted an audit of such training, and sought input from the medical device industry on companies’ experience with respect to
Drugs
The 4th Circuit Court of Appeals has upheld a lower federal court ruling granting summary judgment to Pfizer in multi-district litigation claiming that the company’s Lipitor led to patients developing diabetes. Washington Legal Foundation (WLF), which filed an amicus brief urging vindication of the district court’s application
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab), an anti-PD-1 therapy for treating patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 as determined by an FDA-approved test. The indication was given accelerated approval based on tumor response
Devices
FDA has issued a draft guidance on its “Humanitarian Device Exemption (HDE) Program” that clarifies the current review practices for the regulatory pathway. The document addresses commonly asked questions about HDEs, including FDA actions on HDE applications, post-approval requirements, and special considerations for devices marketed under the program. Additionally,
Drugs
FDA has granted Chiesi USA an orphan drug designation for GPLSCD01, ex-vivo expanded autologous human corneal epithelial cells containing stem cells, for treating limbal stem cell deficiency. The rare and seriously debilitating condition affects one or both eyes due to physical or chemical ocular burns, inflammatory diseases, and hereditary
Devices
FDA has issued a safety update on LivaNova’s Stӧckert 3T Heater-Cooler System (3T) to help prevent the spread of infection related to the use of the devices. This update amplifies livanova’s 4/20 medical device correction announcing the availability of “deep cleaning” services of certain 3Ts in