News

Latest News | 8 March 2013

MDUFA Goals Met in 74-85% of Cases in 2012, FDA Report Says

0 Likes

The US Food and Drug Administration (FDA) has released a new congressional report it wrote regarding its performance under the final fiscal year of the Medical Device User Fee Act (MDUFA), a law Read More...

---

Latest News | 12 September 2012

FDA Slashes Fees for Priority Review Voucher

0 Likes

The US Food and Drug Administration (FDA) has announced the release of fee rates for using tropical disease priority review vouchers for the upcoming year, slashing fees more than 32% from 2012.The Read More...

---

Latest News | 1 June 2012

Post-FDAAA, Regulators Move to Adapt to Changing Risk Models

0 Likes

With all the attention given to the US Food and Drug Administration’s (FDA) approval process, it can sometimes be easy to forget an equal amount of its time is spent on postmarketing issues related, Read More...

---

Latest News | 23 May 2012

Report: REMS Preventing Companies From Making Generic Medicines

0 Likes

The Food and Drug Administration (FDA) Amendments Act of 2007 allowed FDA to institute risk management plans—known as Risk Evaluation and Mitigation Strategies (REMS)—for products with a high Read More...

---

Latest News | 1 May 2012

IOM Issues Report on Studying Safety of Approved Drugs

0 Likes

The Institute of Medicines (IOM) has released a consensus report on ways to improve the US Food and Drug Administraiton’s (FDA) oversight of the safety of already-approved drug products.The report, Read More...

---

Latest News | 4 April 2012

FDA-Backed Collaborative Research Fund Off to Slow, Controversial Start

1 Likes

A fund established under the Food and Drug Administration (FDA) Amendments Act (FDAAA) of 2007 is beginning to ramp up activity after several years of cash-strapped stagnation, but not everyone is Read More...

---

Latest News | 12 March 2012

New FDA Draft Guidance on DTC Television Advertisements

0 Likes

The US Food and Drug Administration (FDA) released new draft guidance 12 March on how FDA intends to review TV advertisements before they are disseminated to the public.Guidance for Industry – Read More...

---

Latest News | 8 March 2012

FDA Releases New Safety Communication Strategy

0 Likes

The US Food and Drug Administration (FDA) released draft guidance on 8 March on how it intends to communicate with the public about drug safety issues, including important topics and emerging Read More...

---

Latest News | 6 March 2012

FDA Releases Report on Postmarketing Study Requirements

0 Likes

The US Food and Drug Administration (FDA) released a report 6 March on the postmarketing studies required of sponsors for products approved under the terms of the FDA Amendments Act (FDAAA) of 2007. Read More...

---

Latest News | 7 February 2012

Politico: FDA Efforts to Create International Uniform Device Code Stalled by OMB

0 Likes

Politico is reporting that efforts spearheaded by Congress five years ago to create a worldwide uniform device identification (UDI) system have stalled out in the regulatory process “for reasons that Read More...

---