News

Search:
 Search

Latest News | 19 June 2013

Republicans Dig Into FDA for Helping to Promote Obamacare Law

0 Likes

If you've been paying close attention to the US Food and Drug Administration's (FDA) emails over the last several weeks, you've likely caught onto something unusual: the agency's promotion of Read More...


Regulatory Update | 19 June 2013

Australia Proposing 12 Month Trial Period for OTC Monograph Process

0 Likes

Australia’s Therapeutic Goods Administration (TGA) opened a consultation on 18 June 2013 on the implementation of a 12-month trial period of an Over-the-Counter (OTC) New Product N2 application (or Read More...


Regulatory Update | 19 June 2013

Australia’s TGA Launches Database of Adverse Event Notifications

0 Likes

Australia’s Therapeutic Goods Administration has launched a new Database of Adverse Event Notifications (DAEN), an online resource that will provide the public and the health care community with Read More...


Latest News | 19 June 2013

Legislators Move to Close Loophole Affecting Sanofi's New Influenza Vaccine

0 Likes

When the US Food and Drug Administration (FDA) approved a new four-strain flu vaccine manufactured by French life sciences manufacturer Sanofi in early June 2013, it didn't just mark a momentous Read More...


Latest News | 19 June 2013

US Throws Out 1995 Standard for Generics Stability Testing, Adopts ICH Standards for NDAs Instead

0 Likes

The US Food and Drug Administration (FDA) has released a new guidance for industry that pertains to stability testing recommendations for generic drug products submitted under 505(j) of the Federal Read More...


Latest News | 19 June 2013

FDA Wants Input on Quality Inspection, Import Procedures Under FDASIA

0 Likes

When US legislators and President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law in July 2012, they did so – among other reasons – in the hope that Read More...


Latest News | 19 June 2013

Regulatory Reconnaissance (19 June 2013)

0 Likes

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US UDI Rule Due out Next Week: FDA Source (MDDI) After two deaths, FDA investigates Lilly Read More...


Latest News | 18 June 2013

NCATS' Development Program Looks to Avoid Regulatory Hurdles for Once-Abandoned Drugs

0 Likes

In 2011, the director of the National Institutes of Health (NIH) reorganized several of his agency's departments into a new center, one intended to upend how pharmaceutical products reach the market Read More...


Latest News | 18 June 2013

Draft Guidance Documents Cover FDA's Expectations for Blood Disorder Treatment Submissions

0 Likes

The US Food and Drug Administration (FDA) this week released two new guidance documents regarding the regulatory considerations for minimally manipulated, unrelated allogeneic placental and umbilical Read More...


Latest News | 18 June 2013

FDA Scrapping IND Approach for Fecal Transplants, Developing Guidance on New Approach

0 Likes

The US Food and Drug Administration (FDA) has found itself mired in – quite literally – a crappy situation. In February 2013, the agency announced that it would reach out to the public in an attempt Read More...


1 2 3 4 5 6 7 8 9 10 ... 239
RF Today is Regulatory Focus' daily news brief. Each edition contains the top global regulatory news stories about pharmaceuticals, medical devices, biotechnology and more. Learn more

New Regulatory Focus Apps for iPad and iPhone