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FDA Finalizes Guidance on the Use of Patient-Reported Outcomes to Support Labeling Claims
…how a person functions or feels about a health condition or its treatment. The instruments can capture significant clinical information that traditional evaluations by health care professionals cannot, such as…
GDUFA Negotiations Completed; Safety, Access, Transparency Are the Primary Aims of the New Program
…state level, where applications coming in can go out within the goal times, by the end of year 5 of the program; A primary application review goal of 10 months…
District Court Decision Acts to Preserve 180-Day Exclusivity Eligibility; An Interesting Solution Around a Forfeiture Catch-22
…. Furthermore, should the sponsor seek final approval after the lapse of many years from initial review and tentative approval, the ANDA would almost certainly have to be reviewed a…
FDA Issues Substantial REMS Draft Guidance
…REMS” should also contain one or more of the REMS elements many are familiar with – medication guides or patient package inserts, communication plans, elements to assure safe use, an…
Wyeth Sues FDA over Generic ZOSYN Approvals; Lawsuit Challenges FDA Inactive Ingredient Policy and Same Labeling Requirement
…safety under the likely conditions of actual use by clinicians. The evidence is directly to the contrary with respect to the approved generic formulation. Wyeth also filed a Motion for…
Discounts on Drugs Covered By Government Programs Would Multiply Under Energy and Commerce Healthcare Reform Bill
…rural referral centers, and inpatient drugs as well as outpatient drugs purchased by these hospitals would be eligible for the 340B discount. In addition, maternal and child health clinics, mental…
House and Senate Members Introduce Long-Shot Resolutions to Repeal FDA’s LDT Final Rule
…the rule could be subject to litigation. A new Presidential Administration could also seek to rescind the rule using notice-and-comment rulemaking, which would need to survive potential legal challenges under…
FDA Issues Final Formal Meetings Guidance; Includes Important Clarifications and Explanations
…may reschedule or cancel a meeting. A decision to reschedule or cancel a meeting is at the discretion of the review division. A rescheduled meeting should be arranged “as soon…
FDA Publishes Memorandum on Use of Symbols to Communicate Nutrition Information
…issues raised during a September 10-11, 2007 hearing titled “Use of Symbols to Communicate Nutrition Information, Consideration of Consumer Studies and Nutritional Criteria,” and discusses FDA’s current plans for front-end…
IOM and NRC Undertake Review of FDA’s Food Safety System; Legislative and Regulatory Recommendations Expected
By Ricardo Carvajal – The Food and Nutrition Board of the Institute of Medicine and the Board on Agriculture and Natural Resources of the National Research Council have established an ad…
Introducing the FDA Law Blog REMS Tracker
…elements provided for in the FDAAA provisions. Those elements include a medication guide or patient package insert, a communication plan to healthcare providers, and elements to assure safe use (e.g.,…
Ranbaxy’s Manufacturing Woes Deepen; FDA Invokes AIP Against Paonta Sahib Facility
By Kurt R. Karst – Earlier today, FDA announced that the Agency was taking the unusual step of invoking its Application Integrity Policy (“AIP”) against Ranbaxy Laboratories Limited’s (“Ranbaxy”) Paonta…
Memo to Food and Feed Ingredient Suppliers: Would Your Auditor Pass Muster with FDA?
By Diane B. McColl & Ricardo Carvajal – In an attempt to improve import safety and further implement its Food Protection Plan, FDA has issued a Guidance for Industry titled…
Federal Agencies Issue Draft Guidance on Good Importer Practices; Retailers and Manufacturers Should Take Note
By Ricardo Carvajal – Several federal agencies, including FDA, have jointly issued a draft guidance for comment purposes only that recommends a wide range of practices intended to help ensure…
FDA Issues Proposed PDUFA V Performance Goals & Procedures
…IV, the proposed PDUFA V agreement establishes a new review model that will apply to all New Molecular Entity (“NME”) NDAs and original BLAs received from October 1, 2012, through…