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Three Alston Bird attorneys urge companies regulated by FDA to engage with the agency on issues involving artificial intelligence and machine learning.

latest-news

Federal Register notice: FDA withdraws the approval of 23 NDAs from multiple applicants because they are no longer marketed.

LATEST NEWS

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Get Involved with FDA on AI/ML: Attorneys

Three Alston Bird attorneys urge companies regulated by FDA to engage with the agency on issues involving artificial intelligence and machine learning.

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23 No-Longer-Marketed NDAs Withdrawn

Federal Register notice: FDA withdraws the approval of 23 NDAs from multiple applicants because they are no longer marketed.

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QS, MDR Issues at Royal Philips China Plant

FDA warns Royal Philips about Quality System and Medical Device Reporting violations at its medical device manufacturing facility in Suzhou, China.

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Annual Report on Postmarketing Requirements

Federal Register notice: FDA makes available its annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments” for fiscal year 2022.

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Animal Drugs

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medical-devices
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Guide on Animal Drug Mfg. Batches

FDA releases a draft guidance entitled “Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.”

medical-devices
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2 Veterinary Medicine Guidances Published

The Center for Veterinary Medicine issues two guidances on data element submission.

medical-devices
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Animal Drug API GMP Guidance

FDA publishes a comprehensive Veterinary International Conference on Harmonization guidance on good manufacturing practice for animal drug APIs.

medical-devices
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Animal MUMS Drug Guidance

FDA publishes a guidance to assist sponsors in seeking approval of new animal drugs for minor uses or minor species.

Biologics

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medical-devices
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‘Complete Response' on Abeona’s PZ-Cel BLA

FDA issues Abeona Therapeutics a complete response letter on a BLA for prademagene zamikeracel (pz-cel), requesting additional information to satisfy ...

medical-devices
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Alvotech/Teva’s Stelara Biosimilar Approved

FDA approves Alvotech and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn) injection for subcutaneous use, a biosimilar to Johnson & Johnson’s Stelar...

medical-devices
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GSK BLA Accepted for Meningococcal Vaccine

FDA accepts for review a GSK BLA for its 5-in-1 meningococcal ABCWY vaccine candidate.

medical-devices
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Enlivex Mixed Results of Sepsis Cell Therapy

Enlivex Therapeutics reports mixed results from its Phase 2 study of Allocetra in patients with sepsis.

FDA General

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medical-devices
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Califf in Hot Seat at 4/11 Oversight Hearing

The House Committee on Oversight and Accountability ratchets up political pressure on FDA by requesting commissioner Robert Califf’s testimony at a 4/...

medical-devices
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Poll Backs FDA Status Quo in Approving Products

In the wake of this week’s U.S. Supreme Court oral arguments on the abortion drug mifepristone, a new Axios/Ipsos poll finds that most Americans say t...

medical-devices
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Weiner Moves to Foreign Inspections Office

FDA Office of Combination Products associate director for policy John Weiner moves to Office of Global Operations director, where he will oversee the ...

medical-devices
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GAO Report Hits FDA on Investigator Retention

A new Government Accountability Office report says FDA needs to evaluate its recruitment and retention efforts to support and maintain its investigato...

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Federal Register

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Info Collection on FDA Social/Behavioral Research

Federal Register notice: FDA seeks comments on an information collection extension entitled “Data To...

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Priority Review Voucher to Orchard Therapeutics

Federal Register notice: FDA issues a priority review voucher to Orchard Therapeutics for its rare p...

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Info Collection on Drug Expedited Programs

Federal Register notice: FDA sends to OMB an information collection extension entitled “Expedited Pr...

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Clinical Trial Innovation Center Established

CDER establishes the Center for Clinical Trial Innovation to support innovative approaches to clinic...

Human Drugs

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23 No-Longer-Marketed NDAs Withdrawn

Federal Register notice: FDA withdraws the approval of 23 NDAs from multiple applicants because they...

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Annual Report on Postmarketing Requirements

Federal Register notice: FDA makes available its annual report entitled “Report on the Performance o...

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Par Recalls 7 Treprostinil Lots

Endo’s Par Pharmaceutical recalls seven lots of treprostinil injection 20g/20mL due to the potential...

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Boxed Warning Ordered on CAR T-Cell Therapies

FDA orders a Boxed Warning to highlight the serious risk of T cell malignancies following administra...

Marketing

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Methodological Rigor Info May Help Promotions: OPDP

CDER Office of Prescription Drug Promotion researchers say disclosing methodological rigor in commun...

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Disease Awareness Ads Can Confuse: FDA Study

CDER Office of Prescription Drug Promotion research demonstrates that consumers may be confused and ...

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Digital Drug Marketing Workshop Themes

A Duke-Margolis Institute for Health Policy report on an FDA-funded virtual workshop on drug digital...

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Industry Faults FDA Research on DTC ‘Implied Claims’

Industry stakeholders question the usefulness and design of proposed CDER Office of Prescription Dru...

Medical Devices

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QS, MDR Issues at Royal Philips China Plant

FDA warns Royal Philips about Quality System and Medical Device Reporting violations at its medical ...

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Exactech Recalls Equinoxe Shoulder Devices

Exactech recalls its Equinoxe Shoulder System devices packaged in defective bags from facilities’ un...

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FDA Warns on OTC Anti-choking Devices

FDA warns against the use of over-the-counter anti-choking devices because they are not approved o...

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Royal Philips’ Zenition 30 Imager Cleared

FDA clears a Royal Philips 510(k) for its Philips Zenition 30 mobile C-arm imaging device.