Latest News
|
21 May 2013
0 Likes 
The US Food and Drug Administration (FDA) is reaching out to the private sector in a bid to help it improve the quality of the postmarketing surveillance data it receives regarding biologic drugs and
Read More...
Latest News
|
21 May 2013
0 Likes
The medical device industry is weighing in on a recent guidance document published by the US Food and Drug Administration (FDA), in several instances calling it deeply flawed and in need of
Read More...
Latest News
|
21 May 2013
0 Likes
The US Food and Drug Administration (FDA) has released a copy of a warning letter sent last week to German pharmaceutical manufacturer Boehringer-Ingelheim, citing alleged manufacturing deficiencies
Read More...
Latest News
|
21 May 2013
0 Likes
US regulators have announced they will soon hold a lengthy meeting to discuss the possibility of standardizing the format and assessment process for risk evaluation and mitigation strategies (REMS), a
Read More...
Latest News
|
21 May 2013
0 Likes
Pharmaceutical manufacturer Sandoz has announced the recall of two lots of its cancer drug methotrexate sodium after it said particulate matter was observed in vials of the drug. The recall is at
Read More...
Latest News
|
21 May 2013
0 Likes
The US Food and Drug Administration (FDA) has announced its third meeting on patient-focused drug development, this time focusing on the views of patients with lung cancer and seeking to identify
Read More...
Latest News
|
21 May 2013
0 Likes
Earlier this year, the US Food and Drug Administration (FDA) said it wanted industry's input regarding how it could establish standardized—and mandatory—labeling for medical devices, postulating that
Read More...
Latest News
|
20 May 2013
0 Likes
Is the right regulatory infrastructure in place in the US to accommodate a coming onslaught of pharmacogenomics data? No, it is not, and regulators need to consider a massive re-alignment of its
Read More...
Latest News
|
20 May 2013
0 Likes
The US Food and Drug Administration (FDA) has announced that it will soon hold the second of at least 20 meetings focused on ways to drive pharmaceutical development in ways that best meet the needs
Read More...
Latest News
|
17 May 2013
0 Likes
Capping off a week of several long-awaited guidance documents, the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) has released yet another guidance document,
Read More...