Drugs
Semler Research Center (SRC), a contract research organization based in Bangalore, India, is suing FDA and some of its inspection and other employees in a California federal court, claiming the agency and its staff violated the company’s Fifth Amendment rights and intentionally inflicted financial distress, interfered with the company’
Drugs
FDA has approved a Shire application for the technology transfer of Cinryze’s (C1 esterase inhibitor [human]) drug product manufacturing process to its Vienna, Austria manufacturing site. This is a second production source for Cinryze, in addition to an undisclosed third-party manufacturer, to meet increased product demand. Cinryze is
Drugs
FDA says it is evaluating the need for regulatory action for 14 new potential signals of a serious risk found in the FDA Adverse Event Reporting System between 7/2017 and 9/2017. A summary sheet identifying the signals also says that labeling was revised for Janssen’s Imbruvica (ibrutinib)
Drugs
Iroko Pharmaceuticals is asking FDA not to approve an Apotex ANDA for a generic form of Zorvolex (diclofenac free acid) because the active ingredient in the proposed generic is not the same as that of Zorvolex, the reference-listed drug. Iroko also says that the ANDA should be rejected because
Drugs
The Senate has voted 55 to 43 to confirm former Eli Lilly executive Alex Azar as HHS secretary, succeeding Tom Price, who was forced to resign after reports that he routinely flew in chartered jets at taxpayer expense. Azar has pledged to take on issues important to both Republicans and
Devices
A 1/10 CDRH Webinar reviewed three changes that were made between a draft and final guidance on technical considerations for additive manufactured medical devices (3D printing). CDRH Additive Manufacturing Working Group member Matthew Di Prima said the changes were made in response to 294 comments from 29 commenters on
Drugs
FDA has granted Berg an orphan drug designation for its leading product candidate BPM31510, indicated for treating pancreatic cancer. The company says it is planning a precision medicine-driven Phase 2 clinical trial for BPM31510-IV alone and in combination with gemcitabine to evaluate the efficacy in patients with advanced
Drugs
A 9/18-9/22/17 FDA inspection at Wong Lap Kwong Medicine Company, Kowloon, Hong Kong, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 1/11 Warning Letter says the specific violations were: * failing to establish adequate written responsibilities and procedures applicable for
FDA Policy/General
Federal Register notice: FDA has announced a 3/22 joint Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee meeting which is expected to discuss the major objectives of a Phase 3 drug development program indicated for treating children with achondroplasia. Study elements to be considered include : Evidence required
Devices
A continuing resolution (see earlier story) that ended the government shutdown and sent FDA staff back to work also included a two-year suspension of the medical device excise tax. The tax was the brainchild of the Obama Administration and was intended to help offset Obamacare healthcare expenses. “This suspension
Drugs
A 6/19-6/23/17 FDA inspection at BBCOS srl, Cherasco, Italy, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a just-released 11/29/17 Warning Letter. Specific violations cited in the letter were: * failing to have, for each batch of
FDA Policy/General
Federal Register notice: FDA has announced a timetable for updates to the FDA Data Standards Catalog for study data submitted electronically in NDAs, ANDAs, BLAs and certain INDs. The initial implementation timetable for submitting standardized study data in electronic format was 24 months for NDAs, ANDAs, and applications, and 36
Devices
The International Medical Device Regulators Forum, which includes FDA, has issued a proposed document, “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices,” to harmonize the documentation and procedures that are used to assess whether a medical device conforms to the regulations that apply in each
FDA Policy/General
Attorney Mark Senak (FleishmanHillard) says that while the number of FDA news releases has remained generally consistent over the last few years, changes in substance and style reflect differences between commissioner Scott Gottlieb and former commissioner Robert Califf. Writing in his Eye on FDA blog, Senak says that the agency
FDA Policy/General
Federal Register notice: FDA has extended the comment period on a draft guidance entitled “The Least Burdensome Provisions: Concept and Principles.” Comments now can be submitted until 3/15. To view the notice, click here.
Drugs
CDER has hired former Pfizer senior vice president Patrizia Cavazzoni as deputy director for operations, replacing Richard Moscicki who joined Pharmaceutical Research and Manufacturers of America late last year as the group’s chief medical officer (see earlier story). Cavazzoni joins Bob Temple, deputy director for clinical science, and Doug
Devices
FDA has cleared a Techlab 510(k) for the Campylobacter Quik Chek and the Campylobacter Chek tests to aid diagnosis of campylobacteriosis, one of the most common causes of diarrheal illness in the U.S. According to Techlab, the Quik Chek is a rapid diagnostic test that detects Campylobacter jejuni
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. BBCOS Cherasco, Italy (11/29/2017): FDA inspected the firm 6/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to have, for each
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says that a Web page and brochure issued by UCLA on the investigational new drug Gallium-68 (Ga68-PSMA) are suggesting in a promotional context that the drug is safe and effective for the purpose for which it is being investigated, or
Drugs
An FDA white paper, “A Regulatory Perspective on the Quality Overall Summary (QOS): Putting the Pieces Together,” defines the QOS as a summary of all quality-related information provided by applicants to regulators in drug marketing or licensing applications, including NDAs, ANDAs, and BLAs in the U.S. It is
Biologics
CBER has issued a list of nine guidance topics it is considering for development during calendar year 2018. The document includes five guidances within the category Blood and Blood Components and four guidances within the category Tissues and Advanced Therapies. It also shows three guidance documents issued since the 7/
Drugs
FDA commissioner Scott Gottlieb said on the NBC Today show that “a lot of people (at FDA) didn’t do what they needed to do in the past” to address the nation’s growing opioid crisis. He said he has taken steps to increase controls over the drugs that kill