Postmarket Safety

Home » Topics » Pharmaceuticals » Postmarket Safety

November 5, 2020
New Postmarket Reporting Forms Detailed in Draft Guidance
The FDA has developed two new documents that it wants drug sponsors to use for annual postmarket reporting and is requesting comments on them in a new draft guidance.
November 4, 2020
Nostrum Laboratories Recalls Metformin Over Nitrosamine Contamination
The company has not received reports of any adverse events linked to the impacted products, the agency said.
November 4, 2020
McKesson Indicates Opioid Settlement Could Reach $21 Billion
Previously, McKesson, AmerisourceBergen and Cardinal Health said they would pay a combined $18 billion to settle more than 3,000 lawsuits.

October 30, 2020
EMA Releases Plan for Limiting Nitrosamine Contamination in Sartans
October 30, 2020
NY’s AG Sets Opioid Trial for Early Next Year
October 30, 2020
NY’s AG Announces New Opioid Trial Start Date, Following Delay
October 22, 2020
New Postmarket Reporting Forms Detailed in Draft Guidance
October 20, 2020
AMAG Fights FDA Call to Withdraw Preterm Birth Injection Drug Makena

October 15, 2020
J&J Adds $1 Billion to Settle Opioid Suit
October 15, 2020
J&J Adds $1 Billion to Settle Opioid Suit
October 7, 2020
FDA Calls for Market Withdrawal of Makena
October 7, 2020
FDA Calls for Market Withdrawal of Makena, Generics
September 10, 2020
DOJ Probes Sanofi, GSK for Failure to Disclose Contaminated Zantac