FDA Policy/General
Recent comments on an FDA proposal to study use of animation in direct-to-consumer advertising highlight concerns about the study as well as its potential benefits. The Advertising Coalition urges the agency to be aware of Supreme Court protections for commercial speech, including advertising. Its letter particularly cites a
Devices
FDA has cleared a Tyto Care Inc. 510(k) for its digital stethoscope, a device that will be part of the firm’s set of telehealth digital examination tools for examining the ears, throat, skin, heart, lungs, and temperature under a cloud-based platform with video conferencing. “By enabling a
FDA Policy/General
Federal Register Notice: FDA is asking for comments on an OMB submission seeking to extend an information collection related to a guidance on “Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.” To view the notice, click here.
FDA Policy/General
Federal Register Notice: FDA is asking for comments on an OMB submission seeking to extend an information collection on recordkeeping requirements related to the agency’s regulations on Human Tissue Intended for Transplantation (21 CFR Part 1270). Under the regulations, facilities are required to meet provisions intended to ensure appropriate
FDA Policy/General
An online World of DTC Marketing blog post by marketing consultant Richard Meyer says that consumers and patients don’t want a social media relationship with drug companies. Responding to changes Facebook is making to become more attractive to drug companies, the author says they won’t work because they
FDA Policy/General
Former CDRH senior executive Jonathan Bernstein describes in a Linkedin post his four-step plan for improving FDA, and especially the Center where he worked. His recommendations are: * find the innovators within the agency, insulate them from bureaucracy, legitimize their work, and empower these teams; * reorganize reviewer assignments to align
Devices
CDRH has been asked to evaluate information that a design flaw in the Hill-Rom Total Care hospital bed reportedly used in many ICUs across the country can put patients at risk of exposure to biohazardous materials. The concern was raised by cardiac surgeon Hooman Noorchashm, whose wife is a
Drugs
Celgene and IBM Watson Health have decided to collaborate to co-develop a new program, IBM Watson for Patient Safety, that aims to enhance pharmacovigilance methods used to collect, assess, monitor, and report adverse drug reactions. The new offering will run on the Watson Health Cloud. “The collaboration will combine
Drugs
FDA says it will be holding a public workshop 5/3/2017 to obtain input from industry and other interested stakeholders on the identification of generic drug regulatory science priorities for FY 2018. The workshop will be held at the FDA White Oak campus, Room 1503A (Great Room), Silver Spring,
Devices
Apollo Endosurgery says it has completed a post-approval study of its Lap-Band AP Adjustable Gastric Band called HERO (Helping Evaluate Reduction in Obesity). The study began in 2009 as part of CDRH’s approval conditions for the device, which is indicated for weight reduction in obese patients. The
Drugs
A 7/20-8/6/15 FDA inspection at Walgreens Home Care (now operating under the name Option Care Enterprises), San Antonio, TX, found serious deficiencies in the firm’s practices for producing sterile drug products that put patients at risk, according to a 10/19 Warning Letter from the
FDA Policy/General
Federal Register Notice: FDA is asking for comments on a submission to OMB seeking to extend an information collection on “Patent Term Restoration Due Diligence Petitions.” Such petition are filed to request revisions to the regulatory review period used to determine patent term restorations. For 2013, 2014 and 2015, a
FDA Policy/General
Federal Register Notice: FDA is asking for comments on a submission to OMB seeking to extend the recordkeeping requirements for institutional review boards. To view the notice, click here.
FDA Policy/General
Federal Register Notice: FDA has extended the comment period for the Medical Device User Fee Amendments reauthorization draft recommendations that were announced in a 10/7 notice. Comments now can be submitted by 11/28. To view the notice, click here.
Drugs
Pfizer says it will discontinue its global clinical development program for bococizumab, an investigational proprotein convertase subtilisin kexin type 9 inhibitor (PCSK9i) intended for treating high cholesterol. “The totality of clinical information now available for bococizumab, taken together with the evolving treatment and market landscape for lipid-lowering agents, indicates
Drugs
FDA commissioner Robert Califf says he believes the drug industry “is near the tipping point where companies can use data sources to collect what they need” for regulatory approval, thus reducing the cost of clinical trials. Speaking in an interview at Cardiovascular Research Foundation’s TCT 2016, Califf said he
Drugs
KMR Group says its annual Clinical Trial Cycle Time report shows that the duration of clinical trials associated with large molecule drugs is significantly longer than it is for trials associated with small molecule drugs. The consultants say that even after accounting for disease complexity and study size, large molecule
Drugs
FDA has accepted for review an Ariad Pharmaceuticals NDA for brigatinib, an investigational oral anaplastic lymphoma kinase (ALK) inhibitor for use in patients with metastatic ALK-positive (ALK+) non-small cell lung cancer (NSCLC) who have progressed on crizotinib. The agency granted a priority review and set a user fee
Drugs
The Washington Legal Foundation and the National Association of Manufacturers are asking the 3rd Circuit Court of Appeals to overturn a Pennsylvania federal court ruling allowing the state of Louisiana to proceed with “copycat” Flonase litigation after the court approved a class-wide settlement that included Louisiana. In an amicus
Drugs
FDA says that Beijing Taiyang Pharmaceutical Co., Beijing, China, limited and/or refused an FDA inspection on 11/16/15. A 10/19 Warning Letter says the firm’s drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment where the owner or operator
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Beijing Taiyang Pharmaceutical Industry Co. Beijing, China (10/19): FDA attempted to inspect the firm 11/2015 and the firm limited the inspection. Agency investigators observed through a window
Drugs
FDA has accepted for priority review a Novartis NDA for LEE011 (ribociclib) as a first-line treatment of postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer in combination with letrozole. The submission is based in data from the