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
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
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
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
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Federal Register notice: FDA has made available a draft guidance on “Labeling for Combined Hormonal Contraceptives.”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Federal Register notice: FDA has made available a draft guidance entitled “Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Non-Structural Disorders.”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.
FDA Policy/General
Clinical trial data integrator Datavant has appointed former FDA chief information officer Eric Perakslis as its chief scientific officer. Based in San Francisco, Datavant’s products are designed to improve the design and interpretation of clinical trials through data integration and artificial intelligence, “increasing the odds of success of clinical
FDA Policy/General
Federal Register notice: FDA has announced a joint Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting 2/14. The committees will discuss a Charleston Laboratories NDA for Hydexor, a fixed-dose combination oral tablet containing hydrocodone, acetaminophen, and promethazine, for the short-
FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher to Spark Therapeutics for gaining BLA approval of Luxturna (voretigene neparvovec), an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. The agency awards priority review vouchers to
FDA Policy/General
The following are summaries of the Federal Register notices published during FDA Webview’s holiday break: ANIMAL DRUGS Federal Register final rule: FDA has issued a final rule that amends the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility
FDA Policy/General
Here are the FDA Warning Letters that were released during the FDA Webview’s holiday break at the end of December: AN Co. Ltd. Gyeonggi-do, Korea (12/13/2017): FDA inspected the firm 5/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) has sent Vanthi (Newtown, PA) a Warning Letter objecting to a medical conference marketing panel for its Lomaira (phentermine hydrochloride USP) tablets. “This panel makes false or misleading claims and/or representations about the risks associated with Lomaira and omits material facts,
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “The Least Burdensome Provisions: Concept and Principles” that intends to eliminate unnecessary burdens that may delay product marketing. It describes the guiding principles and recommended approach for FDA staff and industry to encourage a consistent application of least burdensome
FDA Policy/General
Federal Register notice: FDA has announced the issuance of a priority review voucher to Ultragenyx Pharmaceutical for obtaining approval of a rare pediatric disease product — Mepsevii (vestronidase alfa-vjbk), indicated for treating Mucopolysaccharidosis Type VII. To view the notice, click here.
FDA Policy/General
Federal Register correction notice: FDA is correcting an 11/27 notice entitled “Safety Assessment for Investigational New Drug Safety Reporting; Public Workshop.” The date of the meeting has changed from 1/11/2018 to 3/8/2018. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Prescription Drug Marketing Act of 1987 — Administrative Procedures, Policies, and Requirements, OMB Control Number 0910-0435.” Reporting and recordkeeping requirements found in FDA regulations are intended to: (1) Ban the reimportation of prescription drugs produced in the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211) OMB Control Number 0910-0139.” The information collection requirements in GMP regulations provide FDA with the necessary information to perform its duty to
FDA Policy/General
Federal Register notice: FDA has announced a 3/19/18 public workshop entitled “Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.” The workshop will discuss how interested parties might develop and submit proposed draft guidance on patient experience data for the agency’s
FDA Policy/General
As part of the HHS regulatory priorities for FY 2018, FDA will amend its regulations on the information patients receive for outpatient-administered prescription drugs. And to encourage more consumer-directed care, the agency plans to propose regulations to facilitate access to more treatments for common conditions by using new
FDA Policy/General
FDA commissioner Scott Gottlieb says the agency’s 2018 policy goals include regulatory changes for drugs and medical devices. Writing in an FDA Voice online blog post, Gottlieb says the agency will issue several regulations on drug compounding to help ensure the quality of medicines that patients need. “We want