Biologics
FDA has just released the FDA-483 issued following a 6/18-6/22/18 inspection at Genetech, a San Diego, CA, umbilical cord processing facility. The 10 inspection observations are: * the eligibility of an HCT/P donor was not determined and documented by a responsible person, based on results
Drugs
FDA has granted Purdue Pharma a fast track designation for nalmefene hydrochloride injection, an investigational opioid antagonist for the emergency treatment of known or suspected opioid overdose. Nalmefene has a longer duration of effect than naloxone, another opioid antagonist currently approved for opioid overdose, the company says. The agency designation
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Cancer Clinical Trial Eligibility Criteria: Brain Metastases.” The document provides recommendations on the inclusion of patients with brain metastases in cancer trials. It notes that patients with brain metastases have historically been excluded from clinical trials due to concerns
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.” The document focuses on appropriate patient selection criteria at various stages of drug development, considerations for dosing and pharmacokinetic evaluations, safety monitoring, and ethical considerations. To view
Drugs
FDA has just released the FDA-483 issued following a 6/14-8/1/18 inspection at Immunomedics, a Morris Plains, NJ, clinical trial sponsor. The four observations were: * not all participating investigators were informed of new observations discovered by or reported to the sponsor; * failing to ensure proper monitoring
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies.” The document provides recommendations about the inclusion of patients with organ dysfunction or with prior or concurrent malignancies, which FDA says can maximize the generalizability
Drugs
Janssen Pharmaceutical has submitted a supplemental BLA for Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. The submission, which is based on data from the Phase 3 MAIA (MMY3008) clinical study, is being reviewed
Drugs
FDA has approved an Aerie Pharmaceuticals NDA for Rocklatan (netarsudil and latanoprost) ophthalmic solution, 0.02/0.005% to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Approval is based on data from two Phase 3 studies, MERCURY 1 and MERCURY 2, with Rocklatan
Devices
CDRH is implementing a reorganization that will combine the Office of Compliance, Office of Device Evaluation, Office of Surveillance and Biometrics, and the Office of In Vitro Diagnostics and Radiological Health into one super office — Office of Product Evaluation and Quality. It will be focused on a “Total Product Life
Drugs
A New York federal judge has denied a Teva motion for summary judgment in a whistleblower case over speakers bureau promotion of two of its drugs. In the case, former Teva sales representatives allege that the speaker program for the firm’s Azilect (rasagiline) tablets, a Parkinson’s disease drug,
Drugs
FDA has issued five new guidances intended to encourage a broadening of eligibility criteria to allow more people participating in clinical trials of drugs and biological products for treating cancer, including patients with HIV, HBV, HCV, organ dysfunction, and prior or concurrent malignancies and brain metastases. The agency says that
Drugs
A Texas federal judge has entered a consent decree ordering Guardian Pharmacy Services, a Dallas drug compounder, to stop producing compounded drug products intended to be sterile until the company complies with the Federal Food, Drug, and Cosmetic Act and other requirements. An FDA news release says that despite receiving
FDA Policy/General
Federal Register notice: FDA is correcting a 12/13/2018 notice entitled “Data Integrity and Compliance With Drug CGMP: Questions and Answers; Guidance for Industry; Availability” because it was published with the incorrect docket number. The corrected docket is “FDA–2016–D–1113.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Information To Accompany Humanitarian Device Exemption Applications and Annual Distribution Number Reporting Requirements” (OMB Control Number 0910-0661). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Evaluation of the Program for Enhanced Review Transparency and Communication for New Molecular Entity New Drug Applications and Original Biologics License Applications in Prescription Drug User Fee Acts and 351(k) Biologics License Applications in Biosimilars User
Drugs
A 3/27-4/3/18 FDA inspection at Pfizer’s Hospira Healthcare India drug manufacturing facility in Tamil Nadu, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/4 Warning Letter says the specific violations were: * failing to ensure that laboratory records
Drugs
HHS secretary Alex M. Azar III has appointed National Cancer Institute director Norman E. Sharpless to serve as acting FDA commissioner after Scott Gottlieb leaves next month. Gottlieb announced his resignation to spend more time with his family (see earlier story). Sharpless previously served as director of the University of
Devices
GE Healthcare says the concept of the FDA software precertification program “maintains FDA’s gold standard in ensuring safety and effectiveness of software medical devices, while providing faster access to market for software devices developed by trusted pre-certified organizations.” The company says that accelerated pathway is crucial in helping
FDA Policy/General
The Justice Department says Covidien has agreed to pay $17,477,947 to resolve whistleblower allegations it violated the False Claims Act by providing free or discounted practice development and market development supports to doctors in California and Florida to induce purchase of the company’s vein ablation products. The
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Anicare Pharmaceutical Mumbai, India (2/28): FDA inspected the firm 8/2018 and cited significant GMP violations for finished pharmaceuticals. For example, Anicare failed to establish and follow an
Drugs
FDA has approved an Alkem Laboratories ANDA for a new generic of Diovan (valsartan), an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. The agency says it prioritized the submission’s review to “help relieve the recent shortage of this critical medicine as a result
Drugs
FDA has released the FDA-483 issued following a 2/7-2/15 inspection at Biocon Limited, a Bangalore, India, drug product manufacturer. The two inspection observations were: * procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, adequately validated, and/or followed;