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Published November 25, 2013
Olysio shown to cure patients in less time Read More »
Published November 25, 2013
Will be added to the national stockpile Read More »
By Gil Roth
Published November 21, 2013
Type C meeting reviews cGMP manufacturing space Read More »
Published November 5, 2013
Resolves all issues at Burlington facility Read More »
By Gil Roth
Published November 5, 2013
New protocol may lift clinical hold on uterine fibroid treatment Read More »
By Gil Roth
Published November 1, 2013
Will move cream production to Buena, NJ Read More »
By Gil Roth
Published October 30, 2013
MannKind tries again with inhaled insulin Read More »
Published October 22, 2013
Audits demonstrate custom manufacturing capabilities Read More »
Published October 21, 2013
Pain treatment uses iCeutica’s SoluMatrix Fine Particle Technology Read More »
Published October 21, 2013
Goedheijt and Douwstra to head operations and production Read More »
By Gil Roth
Published October 9, 2013
End-of-Phase II meeting goes smoothly Read More »
FDA’s Quality Agreement Guidance Vs. EMA’s cGMP Regulations
By John Avellanet, Cerulean Associates LLC
Published October 9, 2013
Can you comply with both? Read More »
Published September 12, 2013
Ganetespib to help treat adenocarcinoma Read More »
By Gil Roth
Published September 12, 2013
Ganetespib to help treat adenocarcinoma Read More »
By Gil Roth
Published September 11, 2013
Submit your questions to FDA about the Generic Drug User Fee Amendments Read More »
Published August 8, 2013
Prostate cancer drug to enter clinical trials later this year Read More »
Published August 8, 2013
Prostate cancer drug to enter clinical trials later this year Read More »
Published July 23, 2013
Issues Form 483 for three inspectional observations Read More »
Published June 26, 2013
Wolfratshausen facility supports dosage forms for U.S. distribution Read More »
By Gil Roth
Published May 29, 2013
Stresses use of Quality Agreements between clients, CMOs Read More »
Published March 28, 2013
RVW provides cold storage and visual inspection Read More »
By Gil Roth
Published March 25, 2013
PAI waived, Cook Pharmica to help reduce drug shortage Read More »
Published March 22, 2013
New program combines clinical trial and bioanalytical activities Read More »
Published February 22, 2013
Audits by the Food and Drug Administration (FDA), historically a source of angst, may be generating even more concern. Recently, the FDA has escalated its cGMP compliance inspections by enforcing increasingly complex regulations, gaining greater acce… Read More »
Published February 20, 2013
Expands manufacturing and support facilities in Craigavon Read More »
Published February 6, 2013
U.S. commercial packaging operations underway Read More »
Published February 4, 2013
Will be used for biomarker qualification process Read More »
Published February 1, 2013
PAI triggered by a top pharma company’s NDA filing Read More »
Published January 7, 2013
Successful inspection reviewed procedures and processes for oral solids manufacture Read More »
Published December 6, 2012
Development and manufacturing facility in Suzhou expands capabilities Read More »
Published December 4, 2012
Shanghai facility provides early development services Read More »
Published November 14, 2012
2010 warning letter sited nine issues Read More »
Published October 10, 2012
No observations or recommendations reported Read More »
Published October 8, 2012
Reviewed systems, processes and procedures, with no Form 483 observations Read More »
Published September 26, 2012
Will conduct bioequivalence clinical studies Read More »
Published September 18, 2012
Will commence mumps vaccine production Read More »
Published September 12, 2012
Four newly approved sites expand presence in U.S. market Read More »
Biosimilars, the FDA, and the Supreme Court
By Elizabeth Spar and Tom Wintner, Edwards Wildman Palmer LLP
Published September 6, 2012
Challenges for innovators and biosimilar applicants Read More »


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