FDA Policy/General
FDA needs to revamp its advisory committee process because the agency often stacks the deck with experts that will vote to support its review findings, according to a 12/30 Wall Street Journal opinion piece entitled “The FDA’s Rigged Drug Committees.” The article calls on the incoming Trump Administration
FDA Policy/General
FDA is soliciting comments on proposed research to determine how well consumers and healthcare professionals can identify and respond to deceptive prescription drug promotion. A Federal Register notice says that while studies have looked at the occurrence and influence of deceptive promotion, none have looked at the ability of consumers
Drugs
FDA has approved Biogen’s Spinraza (nusinersen) for treating children and adults with spinal muscular atrophy (SMA). Spinraza, the first drug indicated for this condition, is an injection administered into the fluid surrounding the spinal cord, FDA said in an announcement. The agency said it worked closely with Biogen and
Drugs
FDA has published a guidance, “Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product,” to provide information about the overarching concepts related to clinical pharmacology studies for biosimilar products, approaches for developing the appropriate clinical pharmacology database, and the utility of modeling and simulation for designing
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says that a Zydus Discovery DMCC YouTube video on Lipaglyn (saroglitazar) tablets suggests in a promotional context that the investigational new drug is safe and effective for the purposes for which it is being investigated or otherwise promotes the drug. A 12/
Drugs
FDA Webview has posted Warning Letter summaries for letters released during our holiday break (12/19 to 12/30). They can be accessed by clicking on the link following each letter. Antibioticos do Brasil Sao Paulo,Brazil (12/8): FDA inspected the firm’s manufacturing facility last April and cited
FDA Policy/General
FDA Webview posts the Federal Register summaries for notices released during our holiday break (12/19 to 12/30). ANIMAL DRUGS Guide on Question-based Reviews for Animal Drugs Federal Register Notice: FDA has issued a guidance #234 entitled “Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section
Devices
FDA says it has changed the way in which CDRH communicates about medical device recalls. As of 1/3, it says, information will be posted in the searchable Medical Device Recalls Database much earlier than previously. Now, the information will be posted when a firm takes a correction or removal
Drugs
A 12/7-12/15/15 FDA inspection at Wockhardt Limited, Mumbai, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients, according to a 12/23/16 Warning Letter. The letter says that violations and deviations
FDA Policy/General
A Chiasma YouTube video is promoting the investigational new drug octreotide, including using its proprietary name Mycapssa, according to a 12/21 Notice of Violation issued by the CDER Office of Prescription Drug Promotion to the company. The OPDP letter cites a 4/18/16 Chiasma press release reporting on
FDA Policy/General
Federal Register Notice: FDA has made available a draft guidance on “Premarket Notification (510(k)) Submissions for Bone Anchors.” The document provides recommendations for the information and testing that should be included in premarket submissions for bone anchor(suture anchor) devices used in the appendicular skeleton for attachment of soft
FDA Policy/General
Federal Register Notice: FDA has made available a guidance entitled “Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” The document addresses new provisions added by the Drug Quality and Security Act and updates reporting instructions for drug
Drugs
FDA has published a draft guidance, Providing Regulatory Submissions in Electronic Format—Submission of Manufacturing Establishment Information, discussing the requirements and implementation of the Federal Food, Drug, and Cosmetic Act about valid electronic submissions of manufacturing establishment information (MEI). The document says that 24 months after the draft has been
FDA Policy/General
In an interview with the Washington Post as he prepares to return to Duke University, from which he is on leave, FDA commissioner Robert Califf says that for FDA to be able to make scientifically sound decisions, it needs more evidence about a regulated product’s safety and efficacy. He
Devices
FDA has issued a guidance, Postmarket Management of Cybersecurity in Medical Devices, to inform industry of its recommendations for managing postmarket cybersecurity vulnerabilities for marketed and distributed medical devices. The document says that in addition to the specific recommendations in the guidance, manufacturers are encouraged to address cybersecurity throughout the
Drugs
CDER saw a dramatic drop in innovative new drug approvals in 2016 — just 22 approved (see listing here) which is half as many as were approved in 2015. In his last annual review of the Center’s approval performance presentation before retiring, Office of New Drugs director John Jenkins said
FDA Policy/General
Federal Register Notice: FDA has made available a guidance on “Gifts to FDA: Evaluation and Acceptance.” The HHS secretary has the authority to accept conditional or unconditional gifts on behalf of the U.S., and this authority has been delegated to the FDA commissioner. The document provides the process and
FDA Policy/General
Federal Register Notice: FDA is seeking comments on an information collection related to “Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer from a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure— 21 CFR Part 814.” The agency’
FDA Policy/General
Federal Register Notice: FDA has made available a guidance entitled “Bioequivalence: Blood Level Bioequivalence Study.” The document is intended to harmonize the data recommendations associated with in vivo blood level bioequivalence for veterinary pharmaceutical products. To view the notice, click here.
FDA Policy/General
Federal Register Notice: FDA has made available a guidance on “Gifts to FDA: Evaluation and Acceptance.” The HHS secretary has the authority to accept conditional or unconditional gifts on behalf of the U.S., and this authority has been delegated to the FDA commissioner. The document provides the process and
Drugs
Agios Pharmaceuticals has pulled the plug on its development program involving its second pyruvate kinase-R activator, AG-519, and withdrew its investigational new drug application 12/15 following a verbal notification of an FDA clinical hold. “These decisions do not affect the company’s ongoing global Phase 2 study
Biologics
Janssen Biotech has submitted a Supplemental BLA seeking approval of Stelara (ustekinumab) for treating adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. The human monoclonal antibody, which targets interleukin (IL)-12 and IL-23 cytokines, has been approved in the U.S. for treating adults