FDA Policy/General
A CDER Office of Prescription Drug Promotion (OPDP) Bad Ad Program complaint says that an Eisai sales representative made false and misleading statements to healthcare professionals about the company’s Fycompa (perampanel) tablets and oral suspension. A 10/11 untitled letter says the sales representative made statements providing evidence that
FDA Policy/General
Federal Register notice: FDA has classified the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel into Class 2 (special controls). The classification is in response to a Quidel request for a de novo classification of the Lyra Direct HSV 1 + 2/VZV Assay. The device is identified as
FDA Policy/General
Federal Register notice: FDA has determined the patent extension-related regulatory review period for Janssen Biotech’s Tremfya (guselkumab), indicated for treating adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The review period is 2,968 days, with 2,728 days having
FDA Policy/General
Federal Register notice: FDA has debarred Isachi Gil for six years from providing services in any capacity to a person that has an approved or pending drug product application. FDA based the debarment on findings that Gil was convicted of 12 felonies involving fraud or falsification and that she has
FDA Policy/General
FDA is seeking comments on two proposed studies involving direct-to-consumer and professional drug communications. In the first study, the CDER Office of Prescription Drug Promotion (OPDP) will examine the presence, wording, and prominence of a disclosure communicating information related to a drug’s accelerated approval in direct-to-
Drugs
FDA is evolving to keep pace with technology advances, and one area it wants to focus on is product labeling and new resources and approaches to “appropriately incorporate additional clinically important information into product labeling,” FDA chief of staff Lauren Silvis 10/17 told a Food and Drug Law Institute
FDA Policy/General
Federal Register notice: FDA’s Oncology Center of Excellence Pediatric Oncology Program has announced the creation of a list of molecular targets that have been determined to be substantially relevant to the growth or progression of a pediatric cancer and a list of molecular targets of new cancer drugs and
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a Facebook post and associated comments on MannKind’s Afrezza (insulin human) inhalation powder, for oral inhalation use, make false or misleading claims and/or representations about the risks associated with Afrezza by suggesting that there are no safety concerns associated
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.” The document is is intended to assist sponsors planning to use minimal residual disease as a biomarker in clinical trials.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.” The document describes general approaches to evaluating the benefits and risks of targeted therapeutics within a clinically defined disease where some molecular alterations may occur at low frequencies.
FDA Policy/General
FDA is soliciting comments on proposed research entitled “Disease Awareness and Prescription Drug Promotion on Television.” A Federal Register notice says that when pharmaceutical companies market a new drug, “they often also release disease awareness communications about the medical condition the drug is intended to treat. FDA is interested in
FDA Policy/General
FDA has issued a draft guidance, Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements, covering human drugs and biological products and prescription animal drugs and in DTC promotional materials for over-the-counter animal drugs. The document says quantitative efficacy and risk information refers
Drugs
FDA has outlined a three-factor approach it uses to evaluate whether a drug- or device-related product communication is consistent with the product’s agency-required labeling. The factors come on the heels of a related guidance entitled Medical Product Communications That Are Consistent With the FDA-Required Labeling
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Hanlim Pharm Co. Seocho-Dong, South Korea (10/3): FDA inspected the firm in February and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to
FDA Policy/General
Presumably to avert new FDA regulations or legislation on adding price information in direct-to-consumer (DTC) ads, Pharmaceutical Research and Manufacturers of America (PhRMA) has modified its existing voluntary DTC principles to require member companies to include information in their television ads about how consumers can find pricing details
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings.” The document offers recommendations on planning and conducting more efficient and productive pre-IND meetings. To view the notice, click here.
Biologics
CBER has sent an untitled letter to the operator of two Web sites — http://www.ollereg.com and http://www.innovativeallergy.com — because they were promoting an unapproved product, Ollereg Oral Immunotherapy. Based on statements and claims appearing on the sites, CBER says it “appears that your product is intended
FDA Policy/General
Notice on Pathogen Reduction Workshop Corrected Federal Register notice: FDA corrects a 9/17 notice announcing an 11/29 public workshop entitled “Pathogen Reduction Technologies for Blood Safety.” 10/12/2018 FDA Renews Dermatologic/Ophthalmic Drugs Panel Charter Federal Register notice: FDA renews the charter of its Dermatologic and Ophthalmic
FDA Policy/General
Federal Register notice: FDA is correcting a 9/17 notice announcing an 11/29 public workshop entitled “Pathogen Reduction Technologies for Blood Safety.” The notice was published with an error in the Web site address to register for the workshop. That address is corrected to read “https://www.eventbrite.com/
FDA Policy/General
Federal Register notice: FDA has renewed the charter of its Dermatologic and Ophthalmic Drugs Advisory Committee for an additional two years. The new charter will be in effect until 10/7/2020. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has renewed for two years the charter of its Antimicrobial Drugs Advisory Committee. The new charter will be in effect until 10/7/2020. To view the notice, click here.
FDA Policy/General
CDER director Janet Woodcock says the Center is launching a Task Force on Workplace Harassment and Civility as part of its commitment to a safe and respectful work environment. An e-mail from Woodcock to Center staff says the task force “will initiate critical assessments that will support longer-term