FDA Policy/General
Federal Register notice: CDER has announced its decision to continue the (XXX INSERT XXX) Regulatory Project Management Site Tours and Regulatory Interaction Program. The program gives CDER (XXX DELETE XXX) managers the opportunity to tour pharmaceutical facilities to learn more about drug development processes and to share information about project
FDA Policy/General
Federal Register notice: FDA has finalized a ban on electrical stimulation devices (ESDs) for self-injurious or aggressive behavior. FDA has determined that the devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. The ban includes both new and already
FDA Policy/General
Federal Register notice: FDA is withdrawing its 2006 guidance entitled “Exocrine Pancreatic Insufficiency Drug Products — Submitting NDAs.” Under the Biologics Price Competition and Innovation Act of 2009, FDA no longer can accept NDAs for such products and instead sponsors must submit BLAs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for patent extension purposes for Neurocrine Biosciences’ Ingrezza (valbenazine tosylate) indicated for treating adults with tardive dyskinesia. The review period is 2,071 days, which includes 1,827 days that occurred during the testing phase and 244 days during the
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “The ‘Deemed To Be a License’ Provision of the BPCI Act: Questions and Answers.” The document provides answers to common questions about FDA’s implementation of the statutory provision under which an application for a biological product approved under the
FDA Policy/General
Federal Register notice: FDA has announced the completion of the first phase of its enhanced Purple Book for biologics. The agency says it is transitioning the publication’s current table format to a searchable, public-facing online database entitled “Purple Book: Database of FDA-Licensed Biological Products.” A docket for
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Current Good Manufacturing Practice Regulations for Medicated Feeds — 21 CFR Part 225” (OMB Control Number 0910-0152). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for patent extension purposes for Kyowa Hakko Kirin’s Fasenra (benralizumab), indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older and with an eosinophilic phenotype. The review period is 4,127 days,
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Soft (Hydrophilic) Daily Wear Contact Lenses — Performance Criteria for Safety and Performance Based Pathway.” Under the pathway, a new device can demonstrate performance characteristics of a legally marketed device to receive marketing authorization. Instead of reviewing data from direct
FDA Policy/General
Federal Register notice: FDA has announced a 4/14 public meeting entitled “International Cooperation on Cosmetics Regulation (ICCR) — Preparation for ICCR–14 Meeting.” The meeting intends to invite public input on various topics on regulating cosmetics that may be used in preparing for the ICCR meeting in Brussels 6/8-
FDA Policy/General
Federal Register notice: FDA has made available 33 new and 10 revised draft product-specific guidances that provide recommendations on, among other things, bioequivalence study designs to support ANDAs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Bone Anchors — Premarket Notification (510(k)) Submissions.” The document provides recommendations for 510(k) submissions for bone anchor (suture anchor) devices, including performance testing recommendations and device descriptions. To view the notice, click here.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Acino Products, Hamilton, NJ (2/10): FDA inspected the company in 6/2019 and cited GMP violations for finished pharmaceuticals. For example, Acino failed to maintain buildings used in
FDA Policy/General
Federal Register notice: FDA has determined that CIS Bio International’s Neo Tect Kit was not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. The scintigraphic imaging agent is
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for patent extension purposes for Merck’s Ilumya (tildrakizumab), indicated for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The review period is 3,452days, which includes 3,089 days that occurred
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) has issued Outlook Pharmaceuticals a Warning Letter over a “sponsored link” on Google’s search engine for Procentra (dextroamphetamine sulfate) oral solution because there is no risk information included in the link. The drug is indicated for treating Attention Deficit Hyperactivity Disorder.
Drugs
Sanofi-Aventis has agreed to pay almost $12 million to resolve allegations that it violated the False Claims Act by paying kickbacks to Medicare patients taking its multiple sclerosis drug Lemtrada through a purportedly independent charitable foundation, The Assistance Fund. The Anti-Kickback Statute prohibits drug companies from offering or
FDA Policy/General
CDRH 510(k) eSubmission Template Pilot Federal Register notice: CDRH has announced a voluntary “Electronic Submission Template and Resource (eSTAR) Pilot.” 02/27/2020 Standardized Medicated Feed Assay Limits Guide Federal Register notice: FDA makes available a draft guidance for industry #264 entitled “Standardized Medicated Feed Assay Limits.” 02/27/
FDA Policy/General
Celgene has agreed to acquire for $7 billion Impact Biomedicines and its JAK inhibitor program targeting myelofibrosis. Privately-held Impact is developing fedratinib, a highly selective JAK2 kinase inhibitor, for patients with treatment-naïve myelofibrosis, a bone marrow disorder that disrupts normal production of blood cells. Impact picked up fedratinib
FDA Policy/General
Federal Register notice: CDRH has announced a voluntary “Electronic Submission Template and Resource (eSTAR) Pilot.” The pilot is intended to improve consistency and efficiency in both industry’s preparation and FDA’s review of 510(k) submissions. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance for industry #264 entitled “Standardized Medicated Feed Assay Limits.” The agency says that standardized medicated feed assay limits allow predictability in the review process as sponsors can determine early in the drug development process what assay limits they should expect
FDA Policy/General
Former FDA commissioner Mark McClellan and Friends of Cancer Research founder and chair Ellen Sigal say there are four things FDA can do to build on what has worked in the past and position itself for a strong future. Writing in an online Stat article, McClellan and Sigal highlight emerging