Devices
FDA commissioner Scott Gottlieb, CDRH director Jeffrey Shuren, and Gottlieb chief of staff Lauren Silvis say there is a need for a unified approach to the regulation of in vitro clinical tests to protect patient safety, support innovation, and keep pace with the rapidly evolving technology that is helping find
Devices
FDA has cleared a POPS! Diabetes Care 510(k) for its POPS! one Blood Glucose Monitoring system, a digital health system that combines a user’s phone with a coaching app and a small, portable, and integrated glucose monitor. “People who use the system are also able to review their
Drugs
Tris Pharma has recalled three lots of infant ibuprofen concentrated oral suspension (50 mg per 1.25 mL) due to the potential for the product higher concentrations of ibuprofen than labeled. There is a remote possibility that infants, who may be more susceptible to higher drug potency levels, may be
Drugs
FDA says it has established a docket to obtain data, information, and comments to aid it in assessing the safety and effectiveness of food handler antiseptic drug products (antiseptic hand washes or rubs intended for use in food handling settings) for over-the-counter human use. A Federal Register announcement
Drugs
FDA has released the FDA-483 issued following a 10/8-10/16 inspection at Gadea Biopharma, a Leon, Spain, contract sterile injectable drug products manufacturer. The six inspection observations are: * information stated in the submitted drug application is not exactly as is on site; * labeling equipment is not qualified
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Guidance for Industry: Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification” (OMB Control Number 0910-0806). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for InSightec’s medical device Exablate, indicated for use in the unilateral thalamotomy treatment of idiopathic essential tremor patients with medication-refractory tremor. The regulatory review period has been determined to be 2,050 days, which
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Electronic Submission of Medical Device Registration and Listing — 21 CFR Part 807, Subparts A Through D” (OMB Control Number 0910–0625). To view the notice, click here.
Devices
FDA has approved Olympus’ Spiration Valve System (SVS) for treating severe emphysema, a progressive form of chronic obstructive pulmonary disease (COPD). Approval was based on data from the EMPROVE clinical trial demonstrating that patients treated with the SVS “benefited from statistically significant and clinically meaningful improvements in lung function and
Drugs
Pharmaceutical Research and Manufacturers of America says it “commends FDA on the improvements that have been made” in the agency’s draft guidance on adaptive designs for clinical trials of drugs and biologics over the 2010 guidance. Its comment letter says the current draft “provides clear recommendations for complex design
Devices
FDA has cleared a Subtle Medical 510(k) for the SubtlePET, an artificial intelligence (AI)-powered technology that allows hospitals and imaging centers to enhance images from faster scans. The company says its AI solution “enables completion of more exams in a day compared to conventional PET imaging without the
Devices
FDA has cleared a Bausch & Lomb 510(k) for its Ultra Multifocal for Astigmatism contact lens, a monthly silicone hydrogel lens. The device was designed to be fit during the initial contact lens exam, according to the company. The lenses will be available to eye care professionals and their
Drugs
FDA has accepted a Genentech sBLA for its Tecentriq (atezolizumab) and will give it priority review for a new indication for initial treatment, in combination with carboplatin and etoposide, of people with extensive-stage small cell lung cancer. The agency is expected to make a decision by 3/18/19.
FDA Policy/General
The Department of Justice says that after a year-long review of the “individual accountability policy” enunciated by then-deputy attorney general Sally Yates in a 2015 memo, it is reforming the policy to provide more potential for companies to earn cooperation credit and to resolve cases more quickly. Attorney
Drugs
The Federal Trade Commission (FTC) has approved 5-0 a statement commenting on an FDA draft guidance that aims to deter drug companies from abusing the citizen petition process to delay approval of and competition from generic drugs. The comment says that while some citizen petitions raise genuine issues for
FDA Policy/General
Barox Co. Seongnam, Republic Of Korea (11/28): FDA inspected the drug manufacturing facility in May and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish written responsibilities and procedures applicable to the quality control unit. The firm also failed to exercise strict control over
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Aspire Bariatrics’ medical device Aspire Assist, indicated for use in adults aged 22 or older with a body mass index of 35.0–55.0 kg/m2 who have failed to achieve and maintain weight
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Synergy Pharmaceuticals’ Trulance (plecanatide), indicated in adults for treating chronic idiopathic constipation. The regulatory review period has been determined to be 3,186 days, which included 2,829 days that occurred during the testing phase
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Intercept Pharmaceuticals’ Ocaliva (obeticholic acid), indicated for treating primary biliary cholangitis in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. The
Devices
A 5/7-5/10 FDA inspection at MiBo Medical Group, Dallas, TX, found Quality System Regulation violations in the firm’s manufacturing of the MiBo Thermoflo. An 11/20 Warning Letter says specific violations were: * failing to establish procedures for design control; * failing to establish procedures for corrective and
Drugs
A 5/17-5/18 FDA inspection at Barox Co., Ltd., Seongnam, Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 11/28 Warning Letter says the specific violations were: * failing to establish written responsibilities and procedures applicable to the quality control unit; * failing
Devices
FDA says it has formally recognized the genetic variant information in the Clinical Genome Resource consortium’s ClinGen Expert Curated Human Genetic Data database as a source of valid scientific evidence that can be used to support clinical validity in premarket submissions. FDA says this is a significant step forward