Drugs
FDA has approved a Collegium Pharmaceutical supplemental NDA to enhance the label for Xtampza ER (oxycodone extended-release), an abuse-deterrent, extended-release opioid, for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The sNDA approval,
Drugs
Commenting on Amgen’s federal court suit challenging FDA’s denial of six-months pediatric exclusivity for its Sensipar (cinacalcet), Yale Law School professor Jeanie Kim says in a JAMA Network online article that courts should defer to the agency’s current policy that links “fairly respond” to a study’
Drugs
FDA has approved a Roche PMA for the Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer patients eligible for treatment with Genentech’s (a Roche subsidiary) Alecensa (alectinib). Alecensa gained approval 11/7 based on data from
Devices
A 9/18-10/16/14 FDA inspection found objectionable conditions at a clinical site operated by Dr. William Domb in Upland, CA, who was sponsor/investigator of the significant risk clinical study entitled “Expectations for IRB Research Associations and Oxygen/Ozone Simplified and Suggested Research Treatment Protocols: A Historical
Drugs
A Federal Trade Commission Bureau of Competition report says that for FY 2015, drug companies filed 170 agreements as final resolution of patent disputes between brand and generic drug manufacturers, including 14 settlements that potentially involved pay-for-delay because they contained both explicit compensation from a brand manufacturer to
Drugs
A 5/15-5/19 FDA inspection at Guangdong Zhanjiang Jimin Pharmaceutical Co., Zhanjiang City, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 10/30 Warning Letter. The letter says the firm also manufactures and distributes a product for over-the-
Drugs
The 6th Circuit Court of Appeals has upheld on a 2-1 vote a lower federal court’s dismissal of a whistleblower suit against Bristol-Myers Squibb that was based on allegations of off-label promotion. Attorney Andrew Hull (Hyman, Phelps & McNamara) writes in his firm’s FDA Law
FDA Policy/General
Federal Register notice: FDA has classified genetic health risk assessment systems into Class 2 (special controls). The action was taken in response to a 2016 de novo request submitted by 23andMe for its Personal Genome Service Test. To view the notice, click here.
Drugs
FDA has published a guidance on “Recurrent Herpes Labialis: Developing Drugs for Treatment and Prevention” that discusses the overall development program and clinical trial designs for drug products with an antiviral mechanism of action used to prevent or treat the condition. The guidance does not address drug products used to
FDA Policy/General
Federal Register proposed order: FDA is proposing to reclassify the needle destruction device, renaming the device to “sharps needle destruction device,” from Class 3 into Class 2 (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the agency believes are necessary to provide a
Drugs
Sen. Kamela Harris (D-CA) says she has launched an investigation into the drug maker Alkermes and its efforts to artificially boost sales of Vivitrol, a treatment for opioid addiction. In a statement, Harris referenced news reports indicating that the company attempted to boost sales of its own product while
FDA Policy/General
Federal Register notice: FDA has classified the total 25-hydroxyvitamin D mass spectrometry test system into Class 2 (special controls). The action was in response to a 3/20 de novo request by AB Sciex for its Vitamin D 200M Assay for the Topaz System. To view the notice, click
FDA Policy/General
Federal Register final order: FDA has exempted from premarket notification requirements autosomal recessive carrier screening gene mutation detection systems. The exemption is only applicable to prescription-only tests that have existing or reasonably foreseeable characteristics of commercially distributed devices within the generic type, and where a misdiagnosis would not be
Drugs
FDA has denied a 6/9 petition submitted by Millennial Pharmaceuticals asking that FDA: * not approve any ANDA or 505(b)(2) bortezomib product for any multiple myeloma indication with labeling that omits information on the safe and effective conditions of use for the treatment of relapsed patients; * not approve
Drugs
FDA scientists working in the agency’s Oncology Center of Excellence (OCE) describe the Center’s role in the 5/2017 approval of a cancer treatment based on a biomarker without regard to the tumor’s site. The Experimental Biology and Medicine article describes the accelerated approval given to pembrolizumab
Drugs
FDA has lifted its 9/4 clinical hold on Cellectis’ UCART 123 product candidate Phase 1 trials in acute myeloid leukemia and blastic plasmacytoid dendritic cell neoplasm. The company says it agreed with FDA on a number of revisions to be implemented in the Phase 1 trial protocols. “Cellectis is
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Biomin Industries Tempe, AZ (10/13): FDA inspected the dietary supplement firm and cited its product labeling for unapproved new drug violations. The claims on the labels establish that
Devices
Medical journal editors should encourage authors to disclose CDRH’s role in clinical trial design and execution and to discuss pivotal trial results within the context of regulatory approval, according to an 11/7 JAMA viewpoint piece. “Such policies will increase transparency and understanding of the regulatory approval process and
Drugs
FDA has posted a guidance on “Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery.” The document applies to single-ingredient aspirin, buffered aspirin, and aspirin in combination with an antacid, labeled with cardiovascular-related imagery marketed under the agency’s Tentative Final Monograph
Drugs
FDA has released a guidance on “Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Drugs for Treatment.” The document covers the development of such products, including clinical trial designs, from the pre-IND through the NDA and postmarketing stages. The agency defines direct-acting hepatitis C virus (HCV) antivirals
FDA Policy/General
Federal Register notice: FDA has made available a guidance on “Formal Dispute Resolution: Sponsor Appeals Above the Division Level” that provides recommendations on appealing a scientific or medical issue to the office or center level and provides a structured process for resolving disputes at CDER and CBER. To view the
FDA Policy/General
Federal Register notice: FDA is making available a revised draft guidance entitled “ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence).” The agency is revising the draft guidance because pre-submission of facility information was amended by the FDA Reauthorization Act of 2017.