Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension Usp, 125 Mg/5 Ml due to Possible Underdosing or Overdosing (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
Uganda finalising clinical trials on new injectable HIV drug (Pharmafile)
US FDA accepts Biocon's cancer drug application for review (Economic Times)
AVROBIO Receives Orphan Drug Designation from U.S. FDA for AVR‑RD‑04 for Cystinosis (Press)
FSD Pharma Begins Phase 1 In-human Safety and Tolerability Study of Ultra Micro-Palmitolylethanolamide (PEA) (Press)
Medical Devices
Johnson & Johnson, Apple’s New Virtual Trial Model Shows Early Enrollment Success (Forbes)
Pavmed to resubmit carpal tunnel device 510(k) application (MassDevice)
NeuroPace wins FDA approval of MRI labeling for its neurostim system (MassDevice) (Press)
US: Assorted & Government
Justices Reverse Alito’s Partial Stay Of Generics Discovery (Law360-$)
Assertio, Lupin, Bausch Must Face Buyers' Price-Fixing Suit (Law360-$)
J&J Escapes Suit After Couple Can't ID Pelvic Mesh Maker (Law360-$) (MassDevice)
AARP, Consumer Groups Back Calif. Pay-For-Delay Ban (Law360-$)
FDA Focus: What King & Spalding's Practice Head Is Watching (Law360-$)
Court Determines that Decade’s Worth of Missing Data Must Be Published on ClinicalTrials.gov but Enforcement of Reporting Violations Hinges on FDA Discretion (FDA Law Blog)
USPTO Issues Clarification Regarding Petitions Based on Unintentional Delay (Patent Docs)
Attorney General William P. Barr Delivers Remarks at the Department of Justice's 2020 National Opioid Summit (DOJ)
EMA Unveils Revamped Human Medicines Unit (Pink Sheet-$)
Territorial Limits to Pro-Plaintiff Member State Law Likely To Be OKed In EU (Drug & Device Law)
General Health & Other Interesting Articles
The ‘London Patient,’ Cured of HIV, Reveals his Identity (NYTimes)
Shift in colorectal cancer diagnoses, deaths to younger patients (Reuters)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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