Genentech Sues Lilly Within Hours of Patent Being Issued
Genentech filed a patent infringement suit against Eli Lilly just hours after Genentech was granted a patent for a drug that’s been on the market for nearly two years. Source:…
Judge Throws Out $140 Million Verdict in AbbVie AndroGel Case, Orders New Trial
An Illinois federal judge canned a $140 million verdict against AbbVie and ordered a new trial involving its testosterone replacement therapy, AndroGel, after ruling the jury’s findings were contradictory. Source:…
FDA Issues Draft Labeling Guidance on Indications and Usage
The FDA released draft guidance outlining the information sponsors should include on the Indications and Usage section of drug and biologics labeling. Source: Drug Industry Daily
France to Beef Up Clinical Trial Requirements for Flow Diverter Stents
France’s National Agency for the Safety of Medicines (ANSM) is calling for more exhaustive clinical studies prior to CE marking of flow diverter stents that are implanted to treat intracranial…
Time Is Running Out to Prepare for New EU MDR/IVDR: MedTech Europe
One year after the EU finalized its new medical device and in vitro diagnostics regulations there has been little progress in helping industry transition to the new regulations, according to…
FDA Issues Draft Guidance on Coding for IVDs
The FDA called for consistent coding of in vitro diagnostic tests in a new draft guidance and urged devicemakers to use Logical Observation Identifiers Names and Codes. Source: The GMP…
FDA Offers Labeling Advice for Devices With Lubricious Coatings
The FDA released draft guidance offering recommendations for information to include in labeling for devices with lubricious coating, such as intravascular catheters, guidewires, delivery sheaths and implant delivery systems. Source:…
483 Roundup: FDA Flags Device Firms for CAPAs, MDRs and Complaints
The FDA cited six devicemakers for numerous violations including issues with CAPAs, training, MDRs, complaint handling, improper calibration and validation procedures. Source: The GMP Letter
FDA Updates Software Precertification Program
The FDA released version 0.2 of its Developing Software Precertification Program intended to allow the agency to more efficiently approve software as a medical device (SaMD) without risking patient health…
FDA Suggests Alternatives for Complying With QS Requirements
The FDA put out a list of alternative ways to comply with quality system requirements for device combination products, making suggestions for design controls and quality system regulation exemptions. Source:…
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