Drugs
FDA has granted AngioDynamics an expedited access pathway designation for its NanoKnife System and a proposed indication for use in treating Stage 3 pancreatic cancer. Previously, the device was 510(k)-cleared for the surgical ablation of soft tissue. It uses low energy direct current electrical pulses to permanently open
Drugs
FDA and the Federal Trade Commission have posted joint Warning Letters to the marketers and distributors of 12 opioid cessation products. The letters say the companies are illegally marketing unapproved products with claims about their ability to help treat opioid addiction and withdrawal. An FDA statement says the products have
Drugs
FDA has approved a Perrigo ANDA for a generic version of Allergan’s Estrace Cream (estradiol vaginal cream, USP, 0.01%). It is indicated for treating moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Annual sales of the brand product last year were about $457 million,
Drugs
CDER director Janet Woodcock says that modernizing the new drug review program will be a central theme for the Center in 2018. In a podcast looking ahead to 2018, she says the Center is “looking to react and be able to manage the new science that’s coming forward, all
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
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
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
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
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
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
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
Drugs
Federal Register notice: FDA has reopened the comment period for a 9/26/2017 notice announcing a public hearing on a potential approach for device sponsors who seek to obtain marketing authorization for their products that are intended for a new use with an approved, marketed drug when the drug
Drugs
FDA has approved shelf life extensions on certain Baxter Healthcare intravenous solutions that are in short supply after hurricanes limited production in Puerto Rico (see earlier story). The agency says it is not requiring or recommending that the identified products be relabeled with their new use dates. “However, if replacement
Drugs
FDA has issued South Korea-based Daewoong Pharmaceutical a 10-item Form 483 after an 11/2017 inspection found significant GMP violations at the drug substance and sterile drug manufacturer. For example, the firm was cited for failing to review any unexplained discrepancy and the failure of any batch to
Drugs
Celgene has agreed to fully acquire Juno Therapeutics in a $9 billion deal. Two years ago, the company bought a small stake for $1 billion. The transaction gives Celgene access to Juno’s CAR-T cell technologies. Sanofi has agreed to acquire Waltham, MA-based Bioverativ for about $11.6
Drugs
CDER has released its guidance agenda for documents its plans to release in 2018. It includes two related two drug advertising: “Presenting Quantitative Information in Direct-to-Consumer Promotional Labeling and Advertisements” and “Updating Promotional Materials to Reflect Labeling Changes to Risk Information.” Under clinical/statistical planned guidances, the agenda
Drugs
Federal Register notice: FDA is announcing the availability of a draft guidance entitled “Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products—Content and Format.” The document provides recommendations on the content and format of the product title and