FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Dexcowin Co. Seoul, Korea (2/20): FDA inspected the firm 8/2017 and cited GMP deficiencies with manufactured portable dental diagnostic X-ray devices. For example, the firm failed
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “M7(R1): Assessment and Control of Deoxyribonucleic Acid (DNA) Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk.” The International Council for Harmonization document updates and replaces a 5/2015 guidance under the same title. The new guidance provides
FDA Policy/General
Federal Register notice: FDA has submitted to OMB for approval a new proposed information collection for a drug direct-to-consumer (DTC) broadcast advertising study entitled “Utilization of Adequate Provision Among Low to Non-Internet Users.” The primary focus will concern the ability and willingness of low to non-Internet
Drugs
FDA has announced new research to be conducted on direct-to-consumer (DTC) ads — “Utilization of Adequate Provision Among Low to Non-Internet Users.” Agency regulations require that broadcast advertisements contain a brief summary of side effects and contraindications or that “adequate provision” be made for dissemination of the approved
Drugs
Federal Register notice: FDA has submitted a proposed collection of information to OMB for review and clearance — “Transfer of a Premarket Notification.” The information collection is related to a draft guidance on “Transfer of a Premarket Notification (510(k)) Clearance — Questions and Answers,” which is intended to provide information on
Devices
FDA is alerting healthcare providers to the potential for increased “image artifact” or image voids associated with magnetic resonance angiography imaging for patient follow-up of certain post neurovascular embolization coil procedures. The coils are used in treating brain aneurysms and other vascular abnormalities. “As aneurysms treated with coils may
Drugs
FDA has reaffirmed a 2017 complete response letter denying approval of a Hikma Pharmaceuticals ANDA for a generic version of GlaxoSmithKline’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder). In a just-concluded dispute resolution action, FDA has upheld its complete response action that requested the completion of an
Devices
FDA has cleared a DeGen Medical 510(k) for the E3 MIS Modular Pedicle Screw System for thoraco-lumbar spine. The device is designed to address a wide range of surgical options, pre-assembled or modular screws, straight or curved rods, and titanium or cobalt-chrome rods, according to the
Devices
FDA has approved a Medtronic PMA for its Guardian Connect continuous glucose monitoring (CGM) system for people with diabetes ages 14 to 75 years. The device is described by the company as the first smart standalone CGM system to help people with diabetes stay ahead of high and low glucose
Devices
A jury in Northern District of Indiana federal court has returned a $35 million verdict in favor of plaintiffs Barbara and Anton Kaiser for alleged injuries Barbara suffered from Ethicon’s Prolift transvaginal mesh. The nine jurors found that the company negligently designed the device and failed to adequately warn
Drugs
A revised “Right to Try” bill has been introduced in the House to improve access to experimental treatments for patients. “This updated ‘Right to Try’ bill is the direct result of conversations with our colleagues, the administration, and stakeholders on all sides of the issue,” said House Energy and Commerce
FDA Policy/General
Doryx Not Withdrawn Due to Safety/Effectiveness: FDA Federal Register notice: FDA determines that Mayne Pharma International’s Doryx MPC (doxycycline hyclate), delayed-release tablets, 60 mg, were not withdrawn from sale for safety or effectiveness reasons. 03/09/2018 Advisory Committee Docket Number Corrected Federal Register notice correction: FDA
FDA Policy/General
Biogen has agreed to purchase Pfizer’s PF-04958242, a first-in-class, Phase 2b-ready drug being evaluating to treat several neurological and psychiatric diseases, including schizophrenia. Biogen is paying $75 million upfront for the compound, and the agreement could include up to $515 million in developmental and commercial
FDA Policy/General
Federal Register notice: FDA has determined that Mayne Pharma International’s Doryx MPC (doxycycline hyclate), delayed-release tablets, 60 mg, were not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference Doryx if all other legal and regulatory requirements are met.
Devices
FDA has issued Warning Letters (see below) to all three duodenoscope manufacturers for failing to comply with a 2015 agency order to conduct postmarket surveillance studies to evaluate the effectiveness of reprocessing the devices. The order, which was part of agency actions to prevent patient infections associated with the transmission
Drugs
Federal Register notice: FDA has made available a draft guidance entitled “Proprietary Names for New Animal Drugs.” The document provides recommendations to help new animal drug sponsors develop proprietary names for new animal drugs that do not contribute to medication errors, negatively impact safe use of the drug, or misbrand
Drugs
FDA has approved two ANDAs from Cipla Limited and Aurobindo Pharma for the first generic versions of Amgen’s Sensipar (cinacalcet hydrochloride) tablets for treating a thyroid issue in certain patients on dialysis. The drug is also indicated for treating hypercalcemia in adult patients with parathyroid carcinoma, and severe hypercalcemia
Devices
FDA has approved a Valencia Technologies IDE to conduct a 20-site pivotal clinical trial using its eCoin device technology to treat overactive bladder. The device is intended to work by sending out electrical impulses to the tibial nerve which processes signals to the brain area that controls bladder response.
Drugs
FDA’s Gastrointestinal Drugs Advisory Committee has voted unanimously (15-0) to support approval of a Pfizer supplemental NDA for Xeljanz (tofacitinib) to treat adults with moderately to severely active ulcerative colitis. The positive vote follows a data presentation that showed that after eights weeks of treatment a significantly greater
Drugs
FDA has granted MiMedx Group a regenerative medicine advanced therapy designation for micronized amniotic tissue, AmnioFix Injectable, and its use in treating osteoarthritis of the knee. In granting the designation, FDA acknowledged preliminary clinical evidence that the drug has the potential to address unmet medical needs for the condition, according
Devices
CDRH director Jeffrey Shuren says the Center’s real world evidence (RWE) initiative is a top priority and will help to obtain better and more efficient clinical evidence. For medical technology, RWE can fill gaps in the data used for premarket evaluation of devices and continued monitoring of post market
Drugs
FDA has released the FDA-483 issued following a 2/5-2/23 agency inspection at Pentec Health, a Boothwyn, PA, outsourcing facility. The five specific observations in the document were: * aseptic processing areas are deficient regarding the system for monitoring environmental conditions; * batch production and control records do not