Biologics
FDA has published a guidance, Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271, with recommendations and relevant examples for establishments that manufacture certain non-reproductive human cells, tissues, and cellular
FDA Policy/General
Federal Register notice: FDA has announced a 10/3 public meeting entitled “Development of a List of Pre-DSHEA Dietary Ingredients” that will give stakeholders an opportunity to discuss issues related the agency’s future development of such a list. The list is related to a 2016 draft guidance on
FDA Policy/General
Federal Register notice: FDA has determined that a Novartis NDA for Ritalin LA (methylphenidate hydrochloride) extended-release capsules, 60 mg, was not withdrawn from sale for reasons of safety or effectiveness. The determination will allow the agency to approve ANDAs referencing the NDA if all other legal and regulatory requirements
FDA Policy/General
Federal Register notice: FDA has determined that a Solvay Pharmaceuticals NDA for Gynorest (dydrogesterone) oral tablets, 5 mg and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow the agency to approve ANDAs that reference Gynorest if all other legal and regulatory
Drugs
AbbVie has submitted an NDA for elagolix, an investigational, orally administered gonadotropin-releasing hormone antagonist, indicated for managing endometriosis with associated pain. The submission is based on data from two replicate Phase 3 clinical studies, showing that elagolix demonstrated superiority compared to placebo in reducing three types of endometriosis-associated
Drugs
The Biotechnology Innovation Organization (BIO) says its members appreciate an FDA compliance policy statement on product identifier requirements under the Drug Supply Chain Security Act that postpones enforcement of the requirements for one year until 11/2018. The association says the agency “provided sufficient notice to stakeholders to plan for
Drugs
FDA is recommending that patients not take the potassium-lowering drug sodium polystyrene sulfate (Concordia’s Kayexalate and generics) at the same time as other medicines taken orally. An agency drug safety communication says a study found that sodium polystyrene sulfate binds to many commonly prescribed oral medicines, decreasing the
Drugs
PharMEDium Services has recalled all unexpired lots of oxytocin compounded with lactated ringers and all unexpired lots of oxytocin compounded with lactated ringers and dextrose products that were produced between 7/6 and 8/29. The action is being taken based on laboratory test results indicating a lower than expected
Devices
FDA has cleared an OmniLife Science 510(k) for its proprietary robotic tissue balancing device for use with the company’s OmniBotics robotic-assisted total knee replacement technology platform. The device is intended to provide surgeons with a quantitative tool to actively manage the soft tissue envelope with real-time
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. MB Industria Cirurgica Paulista, Brazil (8/4): FDA inspected the firm’s wound dressing manufacturing facility in March and cited significant GMP violations. For example, the firm failed to
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says that a Cipher Pharmaceuticals professional detail aid for ConZip (tramadol hydrochloride) extended-release capsules for oral use is false or misleading because it omits important risk information associated with using ConZip and other material facts. In an 8/24 Warning Letter,
Drugs
The Court of Appeals for the District of Columbia has upheld a district court decision that FDA acted appropriately in approving Alkermes’ Aristada during a period of exclusivity for Otsuka’s Abilify Maintena. Otsuka had opposed the Alkermes application, saying approval would violate an ongoing period of marketing exclusivity for
Devices
AdvaMed says it does not believe FDA should issue a final guidance based directly on an International Medical Device Regulators Forum (IMDRF) proposed document on software as a medical device. “The IMDRF document is grounded on a classification scheme that does not align with FDA’s statutory framework and, therefore,
Drugs
Six groups are petitioning FDA to seek removal of oral and transmucosal ultra-high dosage unit (UHDU) opioid analgesics from the market. The groups — Association of State and Territorial Health Officials, National Safety Council, Physicians for Responsible Opioid Prescribing, American College of Medical Toxicology, FED UP! Coalition to End the
Devices
FDA has issued a guidance, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices, highlighting considerations the agency believes should be included in the development and design of interoperable medical devices and providing recommendations for the content of premarket submissions and labeling for such devices. The document says
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Providing Regulatory Submissions in Electronic Format — Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling.” This document is mandated under the FDA Safety and Innovation Act by requiring certain submissions be submitted in electronic format,
Drugs
Insmed plans to seek accelerated approval of its inhaled therapy Alis (amikacin) based on data from the CONVERT study in adult patients with treatment-refractory nontuberculous mycobacterial (NTM) lung disease caused by mycobacterium avium complex (MAC). The agency previously granted the product a breakthrough therapy designation, fast track status, and
FDA Policy/General
Federal Register notice: FDA has created a public docket to collect comments related to pediatric post-marketing pharmacovigilance and drug utilization reviews of products posted between 3/11 and 9/12 on the agency’s Web site (see postings) but not presented at an upcoming 9/12 Pediatric Advisory Committee
Drugs
FDA has denied a 2/24/15 Public Citizen petition seeking the immediate removal of ketoconazole 200 mg oral tablets (Janssen’s Nizoral and generics) from the market because its risk of fatal liver failure and adrenal insufficiency and its numerous drug interactions outweigh its limited benefits in treating fungal
Drugs
FDA has denied a United Therapeutics April petition asking that the agency not approve any ANDA referencing Tyvaso (treprostinil) inhalation solution unless the application meets conditions set forth in the petition. The agency denial letter says that because FDA must respond to such petitions within 150 days, it is denying
Devices
FDA says it has learned that QLRAD Netherlands is marketing the RectalPro Endorectal Balloon in the U.S. without marketing clearance or approval. A just-released 7/20 Warning Letter says the agency reviewed the company’s Web site and brochures it distributed at medical conferences in 2015 and 2016
Drugs
FDA has placed a clinical hold on two Cellectis Phase 1 studies involving cell therapy UCART123 in acute myeloid leukemia (AML) and in blastic plasmacytoid dendritic cell neoplasm (BPDCN). The hold was ordered after the company reported one death in the BPDCN clinical trial (ABC study). This was the first