UK Offers Grace Period for Sudden Notified Body Withdrawals
Some devicemakers will be allowed to continue placing their products on the EU market while they deal with the unexpected withdrawal of a notified body, the UK’s Medicines and Healthcare…
FDA Issues Update on Pilot Accreditation Scheme for Conformity Assessments
The FDA has released new details of its pilot accreditation scheme for medical device conformity assessments that it expects to launch later this year. Source: The GMP Letter
483 Roundup: FDA Cites Facilities in the U.S., China and India
The FDA flagged facilities in the U.S., China and India for deficiencies uncovered during agency inspections. Source: Drug GMP Report
Warning Letter Roundup: FDA Warns Six Firms for GMP Lapses
The FDA sent recent warning letters to drug facilities the U.S., Canada, Australia, China and the Caribbean for serious GMP failures. Source: Drug GMP Report
FDA Official Action Indicated Classifications Drop Sharply
Post-inspection Official Action Indicated (OAI) classifications by CDER and CBER have dropped sharply in recent years, according to the latest data from the FDA’s Inspection Classification Database. Source: Drug GMP…
WHO Launches Global Program for Inspections of Sterile Drugmakers
The World Health Organization (WHO) and international regulators including the FDA have launched a pilot program for joint GMP inspections of sterile drug manufacturers. Source: Drug GMP Report
OTC Maker Gets Warning Letter for GMP Violations, Unapproved Drug
Trinidad-based OTC drug manufacturer CGA drew a warning letter from the FDA for serious GMP lapses including inadequate testing and producing an unapproved drug. Source: Drug Industry Daily
Blood Cancer Trials May Use Minimal Residual Disease Measures as Endpoints, Guidance Says
Trials for hematologic malignancies can use measures of minimal residual disease (MRD) as a biomarker, according to a final guidance issued by the FDA that specifies the types and uses…
Gilead Files Counterclaim Against HHS in Truvada Patent Case
Gilead fired back at HHS’s patent infringement suit over its HIV drugs Truvada and Descovy, claiming that the patents the department is suing over are invalid. Source: Drug Industry Daily
ICER Issues Cost-Benefit Analysis on Three Sickle Cell Disease Treatments
The Institute for Clinical and Economic Review (ICER) released a draft cost-benefit analysis comparing three sickle cell disease treatments — Novartis’ Adakveo, Global Blood Therapeutics’ Oxbryta and Emmaus Life Sciences’…
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