CDER RELEASES A NEW PET DRAFT GUIDANCE CDER has just released as a DRAFT the following Guidance for Industry, "Media Fills for Validation of Aseptic Preparation for Positron Emission Tomography (PET) Drugs. The Comment period will be 90 days. Please visit http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273766.pdf to obtain this DRAFT … [Read more...]
CDER MOST FREQUENTLY CITED DRUG OBSERVATIONS – FISCAL YEAR 2010
CDER NAMES THESE TEN (21 CFR 211) Comment The following represent those most frequent Observations that CDER posted for fiscal year 2010 based on a total of 646 FDA Form 483. REFERENCE             … [Read more...]
FDA FILES CONSENT DECREE OF PERMANENT INJUNCTION AGAINST MCNEIL-PPC AND TWO OF ITS OFFICERS
FDA NEWS RELEASE Comment The FDA issued a Consent Decree of Permanent Injunction bypassing a Warning Letter in their persuit of J & J's failure to comply with CGMPs. For Immediate Release: March 10 2011 Media Inquiries: Shelly Burgess, 301-796-4651; shelly.burgess@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA FDA, Justice Department take action against McNeil-PPC … [Read more...]
