Drugs
Drug distributor McKesson Corp. has agreed to pay a record $150 million civil penalty for alleged violations of the Controlled Substances Act, the Justice Department announced 1/17. The nationwide settlement requires McKesson to suspend sales of controlled substances from distribution centers in Colorado, Ohio, Michigan and Florida for multiple
Devices
An ongoing CDRH customer service satisfaction survey score has slipped from 88% of respondents in 2015 reporting that they had received satisfactory responses or information in their Center interactions to a 84% satisfactory rating as of this month. While the survey score has fallen a few points, CDRH says it
Drugs
A 10/27-11/5/15 FDA inspection at Horizon Pharmaceuticals, Riviera Beach, FL, found significant violations of current good manufacturing regulations for finished pharmaceuticals, according to a just-released 12/23/16 Warning Letter from the agency’s Florida District Office. Specific violations included: * failing to establish and follow
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Horizon Pharmaceuticals Riviera Beach, FL (12/23/2016): FDA inspected the firm in 2015 and documented significant GMP violations for finished pharmaceuticals. The letter says the firm failed to
Drugs
Efforts underway in the past year to build a National Medical Evidence Generation Collaborative (EvGen) aim at leveraging previously isolated data systems in a way that ensures that available information collected during healthcare-related activities such as medical research, medical product development, and clinical care, can be brought to bear
Drugs
A 6/6-6/8/16 FDA inspection at Suzhou Pharmaceutical Technology, Suzhou, China, found significant deviations from current good manufacturing practice regulations for active pharmaceutical ingredients (APIs), according to a 1/6 Warning Letter. Specific deviations cited in the letter include: * failing to transfer all quality or regulatory information
Devices
Ropes & Gray attorneys say that medical device manufacturers should review a recent FDA final guidance on postmarket management of medical device cybersecurity and consider how to incorporate its recommendations into their postmarket management activities. In an online regulatory alert, the attorneys say that FDA recommends that manufacturer cybersecurity risk
Devices
The CDRH Office of Compliance issued 17 Warning Letters in 2016, with 16 of them relating to Medical Device Reporting (MDR) violations. Inside Medical Devices, published online by Covington & Burling, says that seven letters determined that the company did not have written MDR procedures that satisfied regulatory requirements, while
Drugs
The Supreme Court has granted Sandoz’ petition and Amgen’s cross-petition that it hear their appeal of a federal appeals court decision in Amgen v. Sandoz. The acting solicitor general had urged the high court to hear the case, saying that the Federal Circuit Court of Appeals erred in
Drugs
FDA has posted a new draft guidance on “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers” dealing with how the agency evaluates firms’ medical product communications that present information that is not contained in, but may still be consistent with, the FDA-required labeling.
FDA Policy/General
One of president-elect Donald Trump’s candidates (see earlier story) for leading FDA has deleted his Twitter posts, presumably to block the public from learning his thoughts and criticisms about the agency and other areas. Entrepreneur Balaji Srinivasan, who founded a genomic testing company and works at the venture
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance on “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.” The document provides recommendations that focus on the analysis of the proposed user interface for any proposed generic drug-device
Drugs
FDA has published a draft guidance, Considerations for Demonstrating Interchangeability with a Reference Product, to help sponsors show that a proposed therapeutic protein product is interchangeable with a reference product for the purpose of submitting a marketing application or supplement under the Biologics Price Competition and Innovation Act (BPCIA). The
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance on “Referencing Approved Drug Products in ANDA Submissions.” The document provides information to potential applicants on how to identify a reference listed drug, reference standard, and the basis of submission in an ANDA submission. To view the guidance, click here.
Devices
FDA is providing an updated Safety Communication to inform users about a design issue with the Pentax ED-3490TK duodenoscope that could increase the risk of patient infection. The communication contains updated recommendations to help prevent the spread of infection associated with the use of these devices. “Cracks and gaps
FDA Policy/General
Forward Pharma A/S has entered into a binding agreement with two wholly owned subsidiaries of Biogen and certain other parties. Under the agreement, Biogen will pay Forward $1.25 billion and it will be obligated to pay Forward royalties of up to 10-20% of net sales of Biogen
Drugs
BIOLOGICS Vaccine Advisory Committee to Review Influenza Vaccines Federal Register Notice: FDA has announced a 3/9 Vaccines and Related Biological Products Advisory Committee meeting. Panel members will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines
FDA Policy/General
The Alliance for a Stronger FDA foresees funding battles for the agency as the incoming Trump Administration looks at deficit reductions through cuts in discretionary spending. In its weekly update (reprinted below), the Alliance predicts that discretionary spending (which makes up a large portion of FDA’s budget) is likely
Devices
FDA says Fujifilm Medical Systems has decided to remove from the market older-model (250/450) duodenoscopes based on the limited number currently in use. Fuji will replace them with the ED-530XT model, in addition to necessary accessories (i.e. brushes) at no cost, a safety alert says. The
FDA Policy/General
Federal Register Notice: FDA has established a docket to receive comments about policy issues that may be considered by the FDA Combination Product Policy Council. The comments are intended to help the agency identify and address combination product policy issues that need clarification through guidance, notice and comment procedures, or
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an information collection extension related to its use of rapid response surveys of community based health care professionals, general type medical facilities, specialized medical facilities (those known for cardiac surgery, obstetrics/gynecology services, pediatric services, etc.), other health care professionals, patients, consumers,
FDA Policy/General
FDA has posted a draft guidance on “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.” The document provides recommendations that focus on the analysis of the proposed user interface for any proposed generic drug-device combination product when compared