House panel explores FDA's efforts to speed complex generics approval | Risperdal punitive damages award against J&J cut from $8B to $6.8M | FDA to launch cloud-based portal for orphan drug requests this year
January 21, 2020
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Drugs & Biologics
House panel explores FDA's efforts to speed complex generics approval
House panel explores FDA's efforts to speed complex generics approval
(Pixabay)
Members of the House Energy and Commerce Committee wrote a letter to FDA Commissioner Stephen Hahn asking for details on the agency's efforts to expedite approval of complex generic drugs. The lawmakers said they want to know if the FDA needs more authority to improve the regulatory process for the drugs.
Regulatory Focus (1/20) 
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Risperdal punitive damages award against J&J cut from $8B to $6.8M
A Philadelphia judge has reduced from $8 billion to $6.8 million the punitive damages awarded to a man who says Johnson & Johnson did not warn that its antipsychotic drug Risperdal could lead to female breast tissue growth in boys. The judge provided no reason for the reduction, and both parties said they will appeal the decision.
Reuters (1/17) 
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FDA to launch cloud-based portal for orphan drug requests this year
The FDA said it will move the filing of orphan drug designation requests from a paper-based process to a cloud-based online portal later this year to ease the submission process. The move is part of the agency's technology modernization plan.
Regulatory Focus (1/17) 
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OAI classifications for device, drug facilities continue to decline
An analysis of FDA's inspection classification database shows the total number of "Official Action Indicated" classifications for device and drug facilities have declined significantly over the last five years. US-based facilities accounted for a large share of OAI classifications while China and India's shares remained steady from 2015 to 2019.
Regulatory Focus (1/20) 
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Medical Devices
Boston Scientific patent case against Micro-Tech to proceed
Boston Scientific can continue its patent suit against Micro-Tech USA and Micro-Tech Nanjing alleging that three of Boston Scientific's patents for its Resolution and Resolution 360 endoscopic hemostatic clips were infringed by Micro-Tech SureClip products, a Delaware federal judge has ruled.
MassDevice (Boston) (1/16) 
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PTAB denies Edwards' petition to challenge Abbott valve repair IP
A petition filed by Edwards Lifesciences to review the patentability of some Abbott intellectual property rights for the MitraClip mitral valve repair device was denied by the Patent Trial and Appeal Board. "[Edwards] has failed to show a reasonable likelihood of success in establishing that any of the challenged claims would have been obvious over [the existing patents]," the board wrote.
MedTech Dive (1/17) 
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FDA to discuss VR, AR technologies in March
The FDA will hold a meeting on virtual and augmented reality devices designed for medical purposes on March 5. The agency will discuss its approach to improving hardware evaluation, standards development and challenge assessment in an effort to advance product development.
MedTech Dive (1/17) 
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Medtronic announces resolution of O2 imaging system issue
Medtronic has announced that the replacement of the internal gantry tractor motor drive in its O-arm O2 imaging system will resolve the potential for the drive belt loosening. The company said it will soon commence scheduling of system service visits based on system age and replacement component availability, and expects to provide the servicing over the next nine months.
MassDevice (Boston) (1/17) 
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Food and Drug Law Institute (FDLI) Highlights
Join Us Today: The USDA Hemp Interim Final Rule: Status, Remaining Issues, and Next Steps | January 21 | 2:00-3:00 PM EST | Live Webinar
Join Us Today: The USDA Hemp Interim Final Rule: Status, Remaining Issues, and Next Steps | January 21 | 2:00-3:00 PM EST | Live Webinar
There's still time to register for today's Hemp Interim Final Rule (IFR) webinar! Learn how the USDA's IFR oversees hemp production and testing, what issues the IFR leaves unresolved, themes that have emerged from the comments USDA has received thus far, and USDA's next steps. Register Now
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Tune in Tomorrow: The CREATES Act Has Passed: What Does It Mean for the Generics Industry? | January 22 | 2:00-3:00 PM EST | Live Webinar
Tune in Tomorrow: The CREATES Act Has Passed: What Does It Mean for the Generics Industry? | January 22 | 2:00-3:00 PM EST | Live Webinar
Register now for tomorrow's CREATES Act webinar! Explore the provisions of the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act), a new legislation that aims to prevent delay in generic drug and biosimilar competition. Discuss its potential impact on the generics, biosimilar, and brand name drug industries. Register Now
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