Articles by Haydia Haniff - BioPharm International

ADVERTISEMENT

ADVERTISEMENT

Articles by Haydia Haniff

Complex Relationship Between FDA and Life Sciences

Dec 9, 2010

Approvals, politics, and user fees are among the issues that make for an uneasy relationship between the US Food and Drug Administration and the life sciences industry, according to findings from a recent PricewaterhouseCoopers (PwC) survey of the industry. This survey, ?Improving America?s Health V,? the fifth such survey performed since 1995, found that although relations between the FDA and the life sciences industry have improved over time, there is still much progress to be made.

Global Hiring Trends in Life Sciences

Nov 11, 2010

ZRG Partners (Westborough, MA) has released its analysis of overall life sciences hiring trends for Q3 2010 and if you live outside of the Americas, hiring trends are generally up.

FDA Seeks to Advance Regulatory Science for Public Health

Oct 14, 2010

In a speech on October 6, 2010, FDA Commissioner Margaret Hamburg outlined the FDA's plan for advancing regulatory science. Her address introduced an FDA document, Advancing Regulatory Science for Public Health, which was released concurrent to her talk.

President's Council and HHS Call for Overhaul of Pandemic Response Programs

Sep 8, 2010

President's Council and HHS Call for Overhaul of Pandemic Response Programs

Genzyme Updates Cerezyme Supply; Responds to Sanofi Bid

Sep 3, 2010

Genzyme Corporation (Cambridge, MA) has reported that production of its Gaucher treatment, Cerezyme is now up to historical averages and they began increasing shipments in August.

Sanofi Pasteur Receives FDA Warning Letter

Aug 12, 2010

On July 22, 2010, Sanofi Pasteur (Lyon, France) received a warning letter from the US Food and Drug Administration, citing deviations from current good manufacturing practices (cGMPs) in the manufacture of certain biological products and bulk drug substances, including Imovax Rabies, Imogam Rabies, Ipol, Act HIB, and Typhim Vi.

Merck: Emerging Markets to Comprise 25% of Global Revenues

Jul 7, 2010

Merck (Whitehouse Station, NJ) expects that emerging markets will account for more than 25% of its global pharmaceutical and vaccine revenue in 2013, based on the implementation of the company?s emerging markets strategy.

New FDA Draft Guidance Lessens Reporting Requirements for Postapproval Manufacturing Changes

Jul 2, 2010

The US Food and Drug Administration has issued a new draft guidance regarding the types of manufacturing changes that can be reported in annual reports.

Podcast: Testing Fermentation Equipment

Jun 8, 2010

ADVERTISEMENT

ADVERTISEMENT

Click here