Drugs
The Federal Trade Commission sued two companies to stop them from falsely claiming that their pills are scientifically proven to alleviate joint pain by growing new bone and cartilage. The joint complaint is against ZyCal Bioceuticals, that has marketed a line of joint pain relief products under the brand name
Drugs
CDER has launched its new Controlled Substances Program (CSP) that encompasses the controlled substances staff and controlled substances initiatives. An internal staff memo says the CSP was established to coordinate CDER activities and emerging issues around controlled substances including prescription opioids, benzodiazepines, and stimulants. The memo says the CSP will
Devices
CDRH has released three new learning modules on the 510(k) third-party review program. The new modules are (1) Overview of the 510(k) Process: Guide for Third-Party Reviewers, (2) Deficiency Writing for Third-Party Reviewers, and (3) Deficiency Writing for Third-Party Reviewers: Examples. Available for each
Devices
FDA has announced a 3/9 workshop on “Detecting Circulating Tumor DNA for Cancer Screening.” The workshop will discuss the appropriate study designs needed to demonstrate the safety and effectiveness of cancer screening tests and to support cancer screening claims. It will also discuss the clinical, scientific, and regulatory challenges
Devices
FDA says the Medtronic recall of its MiniMed 600 Series insulin pumps, due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump's reservoir compartment, is Class 1. If the cartridge is not locked into place, under or over
Devices
FDA has published a guidance, Peripheral Vascular Atherectomy Devices—Premarket Notification 510(k) Submissions, with recommendations for 510(k) submissions for peripheral vascular atherectomy devices. The document says its recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of peripheral vascular submissions. Included in
Drugs
The FDA Office of Clinical Pharmacology (OCP) says its 2019 annual report and the annual report of the Division of Applied Regulatory Science (DARS) are now available. In an online notice, OCP says it is a “dynamic, purpose-driven organization dedicated to promoting and protecting global public health through the
Drugs
Attorney Curtis Dombeck (SheppardMullins) says a 2/10 Federal Circuit Court of Appeals decision has revised the country of origin determination for drugs to be purchased by U.S. government entities. Dombeck writes in an FDA Law Update Blog that the case involved an Acetris Health drug where the active
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “FDA Rapid Response Surveys” (OMB Control Number 0910-0500). The collection covers rapid response surveys for community-based healthcare professionals, general medical facilities, specialized medical facilities (those known for cardiac surgery, obstetrics/gynecology services, pediatric services, etc.
Drugs
Writing in an Annals of Pharmacotherapy editorial, University of Connecticut professor C. Michael White says FDA should act to eliminate the differing rules for completing INDs, different inspection rates, and different inspection intensities that advantage foreign clinical trial sites. “It is a threat to U.S. competitiveness and the quality
Drugs
Merck says that its Phase 3 KEYNOTE-355 trial investigating anti-PD therapy Keytruda (pembrolizumab) in combination with chemotherapy met one of its dual primary endpoints of progression-free survival (PFS) in patients with metastatic triple-negative breast cancer whose tumors expressed PD-L1. An interim analysis found that first-
Drugs
A 2/3-2/11 FDA inspection at the Lupin Pithampur Unit 1 facility closed with two observations on the FDA-483. India online Web site Equity Bulls did not say what the specific observations were. In recent months, Lupin has had inspection issues at its Andhra Pradesh facility, at
Devices
FDA has cleared a Baxter International 510(k) for the Q-NRG+, a metabolic monitoring device that uses indirect calorimetry technology to accurately measure a patient’s calorie needs, or resting energy expenditure. The readings assist healthcare providers when prescribing nutrition therapy, which may include parenteral nutrition, the company says.
Drugs
FDA has released the FDA-483 issued following a 10/8-11/19/19 inspection at SCA Pharmaceuticals, a Windsor, CT, outsourcing facility. The two inspection observations were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of
FDA Policy/General
Federal Register notice: FDA has announced a 3/30 public meeting entitled “Patient-Focused Drug Development for Vitiligo.” The meeting is intended for FDA to obtain patient perspectives on the impact of vitiligo on daily life, patient views on treatment approaches, and decision factors considered when selecting a treatment. To
Drugs
FDA has announced a 4/20-21 workshop entitled “The 12th Annual Sentinel Initiative Public Workshop.” The active medical product surveillance system was established under the FDA Amendments Act of 2007. The workshop, which is being conducted by the Robert J. Margolis, MD, Center for Health Policy, will discuss recent
Drugs
Trevena has resubmitted its NDA for oliceridine for managing moderate-to-severe acute pain. The company expects a six-month review by FDA. The submission is based on the outcome and final minutes of a Type A meeting with FDA, which was conducted to obtain clarity on a 2018 complete
Drugs
Pfizer and Astellas Pharma report that the Phase 3 PROSPER trial demonstrated a statistically significant improvement in overall survival (OS) in men with non-metastatic castration-resistant prostate cancer who were treated with Xtandi (enzalutamide) plus androgen deprivation therapy (ADT) versus placebo plus ADT. OS was a key secondary endpoint
Drugs
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Marco Pharma, Roseburg, OR (1/10) FDA inspected the firm 5/2019 and found serious GMP violations for dietary supplements. For example,
Biologics
Senior CBER officials and executives from BrainStorm Cell Therapeutics have agreed on a potential regulatory pathway for the company’s NurOwn (autologous MSC-NTF cells) to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). The company says that repeated intrathecal administration of NurOwn is currently being evaluated in
Drugs
FDA has placed a clinical hold on a LogicBio Therapeutics IND for LB-001 for treating methylmalonic acidemia (MMA) pending resolution of certain clinical and nonclinical questions. The company says it submitted the IND 1/2020 to support the initiation of a Phase 1/2 clinical trial in patients with
Drugs
The Washington Legal Foundation (WLF) is asking the 9th Circuit Court of Appeals to enjoin a California law that would presume that every drug company patent settlement is unlawful if it gives a generic manufacturer “anything of value,” including an “exclusive license,” and postpones generic market entry for even a