Devices
FDA has cleared a Mevion Medical Systems 510(k) clearance for the Mevion S250i Proton Therapy System that uses its Hyperscan pencil beam scanning (PBS) technology. The technology uses energy layer switching and automated collimation systems to deliver faster, sharper, and more robust PBS proton radiation treatments, the company says.
Drugs
Johnson & Johnson Innovation LLC has entered into more than a dozen new product collaborations to address areas of high unmet medical need. Priority areas that Johnson & Johnson (J&J) says it is devoting resources to include the use of artificial intelligence to detect early signs of Alzheimer’
FDA Policy/General
Federal Register notice: FDA has classified the absorbable perirectal spacer into Class 2 (special controls). The action is in response to a 10/14 de novo classification request by Augmenix, Inc. for its SpaceOAR System. The agency has named the generic type of device absorbable perirectal spacer, and it is
Drugs
HHS Office of Inspector General (OIG) has asked Pharmaceutical and Research Manufacturers of America (PhRMA) for its help finding companies to provide free drugs to patients who were receiving assistance from a charitable group that fell out of favor with the government. A 1/14 OIG letter to PhRMA says
Drugs
AuroMedics Pharma has recalled one lot of ampicillin and sulbactam for injection USP, 1.5 g in a single-dose vial due to the potential for vials to contain glass particles. AuroMedics shipped the entire lot to wholesalers and hospitals nationwide on 2/9/2017, according to a recall notice.
Drugs
FDA has released the Establishment Inspection Report from a 2/27-3/8/17 inspect at the Dr. Reddy’s manufacturing facility in Andhra Pradesh, India. The report says the facility continues to manufacture sterile injectable and tablet products for the U.S. market. At the end of the inspection,
Drugs
FDA has released the FDA-483 issued following a 9/25-9/29/17 inspection at SCA Pharmaceuticals, a Little Rock, AR, outsourcing facility. Specific inspection observations were: * aseptic processing areas are deficient regarding the system for monitoring environmental conditions; * there is a failure to thoroughly review any unexplained discrepancy
Drugs
Federal Register notice or correction: FDA is correcting a notice that appeared 10/24/2017 that announced the withdrawal of 54 ANDAs. That notice inadvertently announced the withdrawal of approval for Watson Labs ANDA for chlorthalidone tablets 25 mg. FDA now confirms that the ANDA approval is still in effect.
Drugs
Federal Register notice: FDA has made available a draft guidance entitled “Good ANDA Submission Practices.” The document highlights common, recurring deficiencies that may delay ANDA approval. It also makes recommendations to applicants on how to avoid these deficiencies with the goal of minimizing the number of review cycles necessary for
Drugs
The Justice Department says it obtained more than $3.7 billion in settlements and judgments from civil cases involving fraud and false claims against the government in FY 2017, with $2.4 billion of the total involving the health care industry. A department news statement says that the health sector
FDA Policy/General
A Washington Legal Foundation (WLF) Legal Pulse online post says a proposal to eliminate the tax exemption for direct-to-consumer drug advertising “is misguided, likely unconstitutional, counter-productive, and would result in worse healthcare outcomes for millions of Americans.” The suggestion to end the tax exemption was included in
Drugs
A 7/17-7/26/17 FDA inspection at American CryoStem Corp., Monmouth Junction, NJ, documented that the firm receives and processes adipose tissue for autologous use, according to a 1/3 Warning Letter. The firm reportedly isolates cellular components from the adipose tissue and processes the tissue into stromal
Drugs
The next FDA Grand Rounds Web cast is scheduled for 1/11 from 12 noon to 1 p.m. on the topic “Ethnicity- and Gender-Related Differences in Alzheimer’s Disease. Presenting will be National Center for Toxicological Research research psychologist Sherry Ferguson and research biologist Vijayalakshmi Varma. “Better understanding
Drugs
iTeos Therapeutics, a biotech firm developing cancer immunotherapies, has regained exclusive worldwide rights from Pfizer to develop EOS200271, a highly selective, clinical-stage indoleamine 2,3-dioxygenase (IDO1) inhibitor. A recent Phase 1 study by Pfizer did not demonstrate the therapy’s efficacy as a single agent in patients with
FDA Policy/General
Federal Register notice: FDA has classified the cervical intraepithelial neoplasia (CIN) test system into Class 2 (special controls). The action responds to a 5/2016 de novo classification request from Ventana Medical Systems for its CINtec Histology device. The device is used to detect a biomarker associated with CIN in
Devices
FDA has cleared a Cerebrotech Medical Systems 510(k) for the Cerebrotech Visor, previously known as the CMS-5000 Intracranial Fluids Monitor. The clearance includes a broad indication for use as an aid in assessing fluid volume differences between the cerebral hemispheres in patients undergoing neurologic assessment. The company says
FDA Policy/General
A Health Affairs year-in-review says that one of the biggest drug policy stories in 2017 was the bipartisan cooperation that led to passage of the FDA Reauthorization Act of 2017 that continued the FDA user fee program. The review also says that FDA commissioner Scott Gottlieb has established
Drugs
FDA has cleared a Cerebrotech Medical Systems 510(k) for the Cerebrotech Visor, previously known as the CMS-5000 Intracranial Fluids Monitor. The clearance includes a broad indication for use as an aid in assessing fluid volume differences between the cerebral hemispheres in patients undergoing neurologic assessment. The company says
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Labeling for Combined Hormonal Contraceptives.” The document provides recommendations on information that should be included in the prescribing information for combined hormonal contraceptives, which contain estrogen and progestin. Such products include combined oral contraceptives, as well as non-oral
FDA Policy/General
Federal Register notice: FDA has announced a 3/23 Pediatric Advisory Committee meeting. Panel members are scheduled to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003. To view the notice, click here.
FDA Policy/General
Some 60 groups representing patients, healthcare providers, public health experts, women, people of color, workers, consumers, and people of faith are telling senators that it would be detrimental to Americans for Alex Azar to be named HHS secretary. A 1/3 letter to senators (link in Public Citizen statement) says
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Non-Structural Disorders.” The document provides key design considerations, including recommendations for patient enrollment criteria and efficacy endpoints, for clinical trials to establish effectiveness for such drugs.