Drugs
A 2/8-3/1/18 FDA inspection at the Pure Source drug manufacturing facility in Doral, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 2/20 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of
Drugs
On the heels of a critical CBS 60 Minutes report that claimed FDA ignited the current opioid crisis, commissioner Scott Gottlieb says the agency will require opioid manufacturers to conduct long-term studies to evaluate whether the drugs maintain their effectiveness with chronic use. “This is a critical question,” he
FDA Policy/General
Federal Register notice: FDA has issued a proposed rule to put into effect a final monograph for nonprescription, over-the-counter (OTC) sunscreen drug products. The proposed rule describes the conditions under which OTC sunscreen monograph products would be generally recognized as safe and effective and not misbranded. It is
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations.” The document revises and replaces part of a 2002 FDA guidance on “Food- Effect Bioavailability and Fed Bioequivalence Studies.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Bioavailability Studies Submitted in NDAs or INDs — General Considerations.” The document revises and replaces an FDA 3/2014 draft guidance on “Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations.’’ To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has reopened the comment period for an 11/20/2018 notice entitled “Prescription Drug-Use-Related Software; Establishment of a Public Docket; Request for Comments.” Electronic or written comments should be submitted by 4/29. To view the notice, click here.
Drugs
FDA has released the FDA-483 with two observations it issued following a 12/3-12/14/18 inspection at Aurobindo Pharma Unit 4, Hyderabad, Telangana, India. Specific inspection observations were: * failing to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; and
Devices
FDA is joining the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services to launch a tri-agency task force to help leverage the expertise of each agency to advance rapid development and deployment of diagnostic tests in clinical and public health laboratories during public
Drugs
FDA has approved a Romeg Therapeutics 505(b)(2) NDA for Gloperba (colchicine) Oral solution, 0.6 mg/5 mL for prophylaxis of gout flares in adults. Gloperba is the first liquid formulation of colchicine approved by FDA for this indication. “Existing therapies do not adequately address the physician’s
Drugs
In a decision that may ultimately affect FDA as well, the 3rd Circuit Court of Appeals has issued a ruling in FTC v. Shire ViroPharma that attorney Jennifer Thomas (Hyman, Phelps & McNamara) says “could set the Federal Trade Commission’s litigation authority back decades.” Writing in her firm’s
Drugs
FDA has released the FDA-483 issued following a 1/7-1/15 inspection at the Dr. Reddy’s Laboratories facility in Andhra, Pradesh, India. The four inspection observations in the report were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its
Devices
FDA has cleared a Sensus Healthcare 510(k) for the Sculptura radiation oncology system, a single radiation treatment used during cancer surgery. The robotic intraoperative radiation therapy system uses patented Beam Sculpting capabilities to treat various cancers during surgery. The first device has been installed at the University of Pennsylvania&
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Pure Source Doral, FL (2/20): FDA inspected the firm 2/2018 and cited significant GMP violations for finished pharmaceuticals. For example, Pure Source failed to thoroughly investigate an
Drugs
Pharmaceutical Manufacturing Research Services chief executive Ed Thompson told CBS’s 60 Minutes 2/24 that FDA ignited the current opioid crisis when in 2001, and pressured by Big Pharma, the agency wrongly approved a label expansion for Purdue Pharma’s Oxycontin to be used for chronic, long-term pain
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances on, among other things, the design of bioequivalence studies to support ANDAs. To view the notice, click here.
Devices
FDA has issued a Warning Letter to Total Thermal Imaging (La Mesa, CA) for illegally marketing and distributing an unapproved thermography device as a sole screening device for breast cancer and other diseases. The agency also issued a safety communication to warn patients that thermography is not cleared as an
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Implanted Brain-Computer Interface Devices for Patients with Paralysis or Amputation — Nonclinical Testing and Clinical Considerations.” The document defines implanted brain-computer interface devices as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor
FDA Policy/General
Federal Register notice: FDA has reopened the comment period for an 11/15/2018 proposed rule on “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.” Electronic or written comments should be submitted by 3/7. To view the notice, click here.
Devices
FDA has cleared an Alphatec Holdings 510(k) for the SafeOp neuromonitoring system for use in real-time intraoperative nerve location and health assessments during spinal surgery. The company describes the device’s next-generation technology advances as two intraoperative neurophysiological monitoring modalities: somatosensory evoked potential (SSEP), and electromyography (EMG)
Drugs
FDA has published two draft guidances to help drug developers get agency approval. The first draft guidance, “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations,” provides recommendations to sponsors planning to conduct food-effect studies for orally administered drug products as part of INDs,
Drugs
FDA has approved a Taiho Oncology NDA for Lonsurf (trifluridine and tipiracil) for treating adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy. Approval was based on data from the global, randomized, Phase 3 TAGS trial evaluating Lonsurf plus best
Devices
FDA has cleared a Spirosure 510(k) for its Fenom Pro Asthma Monitor for use by allergists, immunologists and pulmonologists to help patients manage asthma by measuring the fraction of exhaled nitric oxide (FeNO) in their patients’ breath. FeNO is an established biomarker for airway inflammation in human exhaled breath,