FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs.” The document recommends approaches that clinical trial sponsors can take to broaden eligibility criteria, when scientifically and clinically appropriate, and increase enrollment of underrepresented populations
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Guidance for Industry on Establishing That a Tobacco Product Was Commercially Marketed in the United States as of 2/15/2007,” (OMB Control Number 0910-0775). To view the notice, click here.
FDA Policy/General
The House Appropriations Committee has marked-up and passed the fiscal year 2020 Agriculture/FDA appropriations bill that would provide the agency with an increase in budget authority of 6% ($184 million) over 2019 levels. A House combined press release and statement said: “The FDA receives a total of $3.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. ActiveHerb Technology, San Diego, CA (5/15): FDA inspected the firm 9/2018 and determined that it was selling unapproved new drugs that were misbranded. FDA documented the firm’
FDA Policy/General
Federal Register notice: FDA has permitted the redemption of a priority review voucher associated with the recent approval of a Novartis NDA for Mayzent (siponimod) tablets, indicated for treating adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. To view
FDA Policy/General
FDA chief of staff Lauren Silvis has announced her departure from the agency later this month. She became chief of staff to former commissioner Scott Gottlieb 4/2017 after serving two years as CDRH deputy Center director for policy. Prior to joining FDA in 2015, she was a partner at
FDA Policy/General
Info Collection Extension on Supplement Notifications Federal Register notice: FDA submits to OMB an information collection extension entitled “Food Labeling; Notification Procedures for Statements on Dietary Supplements — 21 CFR 101.93.” 05/31/2019 Comments Sought on Opioid Unit-of-Use Packaging Federal Register notice: FDA seeks public comments on
FDA Policy/General
Johnson & Johnson Consumer has successfully completed the acquisition of Vogue International LLC, a privately-held company focused on the marketing, development and distribution of salon-influenced and nature inspired hair care and other personal care products, for $3.3 billion in cash. Icagen, Inc. says it has acquired Sanofi’
FDA Policy/General
DEVICES Entrotech Life has received FDA 510(k) clearance for its ChloraDerm, an edge-to-edge transparent film dressing to provide a chlorhexidine matrix for wound and catheter site protection for up to seven days. “Compared to common non-antimicrobial dressings ChloraDerm demonstrates substantially greater effectiveness against multi-drug-resistant
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Food Labeling; Notification Procedures for Statements on Dietary Supplements — 21 CFR 101.93” (OMB Control Number 0910–0331). FDA’s regulations require that, no later than 30 days after the first marketing, it be notified about specific
FDA Policy/General
Federal Register notice: FDA has announced the establishment of a docket to solicit public comments on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy to require that certain solid, oral dosage forms of immediate-release opioid analgesics commonly prescribed for treatment of acute pain be made
FDA Policy/General
Federal Register notice: FDA has announced a 7/17 public workshop entitled “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations.” The workshop is intended to capture stakeholder experiences with risk-based approaches for monitoring clinical investigations and gather stakeholder input on opportunities to further the implementation of
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) has issued Vivus an untitled letter over false and misleading claims made on its Web page for weight-loss drug Qsymia (phentermine and topiramate extended-release) capsules. According to the letter, the page makes false/misleading claims and representations about the drug’
FDA Policy/General
FDA 5/31 kicked off a long-awaited public hearing on “Scientific Data and Information About Products Containing Cannabis or Cannabis-Derived Compounds” by reiterating concerns about drug-like claims touted by product marketers. “Our biggest concern is the marketing of products that put the health and safety of consumers
FDA Policy/General
Federal Register notice: FDA has determined that AbbVie’s Lupron (leuprolide acetate) injection, 1 mg/0.2 mL, was not withdrawn from sale for reasons of safety or effectiveness. The determination allows FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal
FDA Policy/General
Federal Register notice correction: FDA is correcting a 5/10 notice entitled “Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations; Guidance for Industry; Availability” that was published with the incorrect docket number. The correct docket is
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act,” (OMB Control Number 0910-0641). FDA’s regulations require that the label of a
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: AMMD Labs Pompano Beach, FL (5/2): FDA inspected the firm 9/2018 and cited significant GMP violations for finished pharmaceuticals. For
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “FDA Adverse Event Reports; Electronic Submissions — 21 CFR 310.305, 314.80, 314.98, 314.540,329.100,514.80, 600.80, 1271.350, and Part 803” (OMB Control Number 0910-0645). FDA requires that product sponsors
FDA Policy/General
Federal Register notice: FDA has extended the comment period on a draft guidance entitled “Review and Update of Device Establishment Inspection Processes and Standards.” Comments are now due by 6/27. To view the notice, click here.
FDA Policy/General
Regulatory Review Period for Edwards Aortic Valve Federal Register notice: FDA determines that the regulatory review period for Edwards Lifesciences’ Edwards Intuity Elite Aortic Valve is 1,508 days. 05/24/2019 Final Guide on Compounding Bulks List Federal Register notice: FDA makes available a final guidance entitled “Section 503A
FDA Policy/General
Federal Register notice: FDA has determined that the regulatory review period for Edwards Lifesciences’ Edwards Intuity Elite Aortic Valve is 1,508 days, which includes 1,203 days that occurred during the testing phase and 305 days during the approval phase. The device is indicated for the replacement of diseased,