Latest News
|
2 May 2013
0 Likes 
Just hours after approving an application from Teva Women's Health allowing the company to market its product over-the-counter (OTC) to women as young as 15 years of age, the US Food and Drug
Read More...
Latest News
|
2 May 2013
0 Likes
Brazil’s National Health Surveillance Agency (Anvisa) has opened a Public Consultation on proposed Good Regulatory Practices (GRPs), which establishes the standards and procedures that are to be
Read More...
Latest News
|
2 May 2013
0 Likes
The European Medicines Agency (EMA) has just published a new biosimilars draft guideline for consultation that outlines the general principles that industry must take into account when developing an
Read More...
Latest News
|
2 May 2013
4 Likes
The US Food and Drug Administration (FDA) is, like many device regulatory bodies around the world, preparing to implement a huge overhaul of its medical device systems. Known as the Unique Device
Read More...
Latest News
|
2 May 2013
1 Likes
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US FDA Seeks Think Tank Help On Opioid Drug Trials (Pharmalot) Novartis Hit With Four FDA
Read More...
Latest News
|
1 May 2013
0 Likes
Is the US government doing enough to protect children from the threat of a medical emergency caused by a chemical, biological, radiological or nuclear accident? Not as much as it could be, concludes a
Read More...
Latest News
|
1 May 2013
0 Likes
The US Food and Drug Administration (FDA) is announcing the launch of a new pilot program that it says will use a common data format to automate part of the submission process for Field Alert Reports
Read More...
Latest News
|
1 May 2013
1 Likes
In a major announcement made late Tuesday, the US Food and Drug Administration (FDA) announced that it had expanded the approved indications for Plan B One Step, a birth control medication
Read More...
Latest News
|
1 May 2013
2 Likes
The US Food and Drug Administration (FDA) recently set out to get patients and patient groups considerably more involved in the regulatory process through its Patient Network, a new website and
Read More...
Latest News
|
1 May 2013
0 Likes
US regulators have approved a new product intended to treat an extremely rare disease known as nephropathic cystinosis, a disease that affects fewer than 3,000 patients worldwide and causes a buildup
Read More...