FDA Policy/General
FDA 5/31 kicked off a long-awaited public hearing on “Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds” by reiterating concerns about drug-like claims touted by product marketers. “Our biggest concern is the marketing of products that put the health and safety of consumers
Biologics
CBER’s Office of Compliance and Biologics Quality has sent an untitled letter to R3 Stem Cell because its Web site promotes its “regenerative stem cell therapies” without an approved BLA. “We note that your products are intended to treat a variety of serious or life-threatening diseases or conditions,
Devices
FDA has approved a Stryker PMA for the Neuroform Atlas Stent System, an aneurysm adjunctive stent for treating wide-neck, intracranial aneurysms in conjunction with embolic detachable coils. The device was previously approved under a humanitarian device exemption restricting use to specific hospitals with institutional review board approval. Approval was
Drugs
CDER Office of Surveillance and Epidemiology director Gerald Dal Pan says that although the number of reports to the FDA Adverse Event Reporting System (FAERS) reached a record of more than two million in 2018, that does not suggest that FDA-approved drugs have become riskier. In a CDER Conversation:
FDA Policy/General
Federal Register notice: FDA has determined that AbbVie’s Lupron (leuprolide acetate) injection, 1 mg/0.2 mL, was not withdrawn from sale for reasons of safety or effectiveness. The determination allows FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal
Drugs
FDA has announced a 7/17 public workshop entitled “Improving the Implementation of Risk-Based Monitoring (RBM) Approaches of Clinical Investigations.” The workshop is intended to capture stakeholder experiences with risk-based approaches to monitoring of clinical investigations and gather stakeholder input on opportunities to further implement risk-based approaches
Drugs
FDA has approved an Astellas Pharma supplemental NDA to update the U.S. product labeling for Xospata (gilteritinib) to include final analysis data from the ADMIRAL trial. The data demonstrated improvement in overall survival in patients treated with gilteritinib monotherapy versus salvage chemotherapy in adult patients with relapsed or refractory
Drugs
Five FDAers working in various CDER positions involving cancer drugs and treatment say the agency is working to help resolve a problem that occurs when patients and their families don’t understand information they are given about a cancer diagnosis and treatment options. Writing in an open-source article in
Devices
FDA has cleared a Medivis 510(k) for its SurgicalAR, an augmented reality technology platform for surgical applications and its clinical use in the operating room. The company says the device “integrates the latest advancements in augmented reality, artificial intelligence, and computer vision to advance surgical visualization, thereby decreasing surgical
Devices
FDA has granted Resolution Bioscience a Breakthrough Device Designation for the Resolution HRD liquid biopsy assay, a qualitative in vitro diagnostic to detect sequence variations in key genes related to homologous recombination deficiency for single nucleotide variants, indels, and copy number variants. The company says it plans to seek device
Drugs
The Justice Department says Almirall (formerly Aqua Pharmaceuticals) will pay $3.5 million to resolve a whistleblower’s allegations that it used illegal kickbacks to incentivize doctors to prescribe the company’s dermatology drugs. A department statement says the settlement resolves allegations that between 2012 and 2017 Aqua knowingly paid
Devices
Terumo Medical has recalled its Solopath Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System due to the potential for the tip to dislodge from the outer rim of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface
Drugs
Epizyme has submitted an NDA seeking accelerated approval of tazemetostat for treating patients with metastatic or locally advanced epithelioid sarcoma not eligible for curative surgery. The company describes Tazemetostat is an oral, first-in-class, EZH2 inhibitor that it discovered and is developing for various cancers and treatment settings. The
Drugs
GlaxoSmithKline says a draft FDA guidance on quality considerations for continuous manufacturing is “a good first step toward establishing current Good Manufacturing Practices around emerging continuous manufacturing technology.” The company says it expects that once the International Conference on Harmonization Q13 guideline on continuous manufacturing of drug substances and drug
Drugs
Merck says it would be helpful if FDA would include in a draft guidance on bioavailability studies submitted in NDAs or INDs the reason or trigger for revising the 3/2014 draft guidance and a summary of key changes from the 2014 document. Pharmaceutical Research and Manufacturers of America (PhRMA)
Drugs
FDA has opened a public docket to receive comments on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy to require that certain solid, oral dosage forms of immediate-release opioid analgesics be made available in fixed-quantity, unit-of-use blister packaging for outpatient dispensing. A
FDA Policy/General
Federal Register notice correction: FDA is correcting a 5/10 notice entitled “Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability” that was published with the incorrect docket number. The correct docket is
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act,” (OMB Control Number 0910-0641). FDA’s regulations require that the label of a
Drugs
Heritage Pharmaceuticals has recalled one lot of amikacin sulfate injection, USP, 1g/4 mL (250mg/mL) and one lot of prochlorperazine edisylate injection, USP, 10mg/2mL (5mg/mL) due to microbial growth having been detected in each lot. The drug products are manufactured by Emcure Pharmaceuticals and distributed by Heritage.
Drugs
An FDA 5/13 public meeting on the future of insulin biosimilars heard from stakeholders representing many different perspectives. Mylan head of global clinical research Abhijit Barve said any “additional requirements not based on risk or clinical relevance will only be a barrier to development” of biosimilar insulins. “In fact,
Drugs
A recent updated Justice Department guidance intended to help department prosecutors evaluate corporate compliance programs in the context of investigations of business entities confirms that three fundamental issues are relevant to any such evaluation. Attorneys Gregory Brower and Stanley Garnett (Brownstein Hyatt Farber Schreck) write in a Washington Legal Foundation
Drugs
FDA has released two documents relating to its work on regenerative medicine therapies. The first, Standards Development for Regenerative Medicine Therapies, says the agency is working with the National Institute of Standards and Technology and stakeholders to facilitate efforts to coordinate development of standards for regenerative medicine therapies as required