Articles by Angie Drakulich - BioPharm International

ADVERTISEMENT

ADVERTISEMENT

Articles by Angie Drakulich

FDA Guides the Way to Biosimilars in the US

Has the long-awaited guidance answered all of the industry's questions?
Mar 1, 2012

Has the long-awaited guidance answered all of the industry's questions?

Sustainable Investment

Industry announces plans for year ahead at annual JPMorgan Global Healthcare Conference.
Feb 1, 2012

Industry announces plans for year ahead at annual JPMorgan Global Healthcare Conference.

Here's to a Year of Compromise

The benefits of harmonization may be on industry's wish list, but buying into change is another story.
Jan 1, 2012

The benefits of harmonization may be on industry's wish list, but buying into change is another story.

USAID Moves Global Healthcare Initiatives Forward

Government plans require investment, partnership, and industry collaboration.
Jan 1, 2012

Government plans require investment, partnership, and industry collaboration.

FDA and Department of Health Address Drug Shortages

Sep 20, 2011

FDA Commissioner Margaret Hamburg and US Assistant Secretary for Health Howard Koh released a statement on Sept. 9, 2011, aimed at a stakeholder meeting held at the US Department of Health and Human Services (HHS) to address the growing problem of drug shortages in the United States. The shortages affect many necessary drugs, including those for cancer, anesthesia, influenza, and other critical conditions.

FDA Issues Letter to Pfizer Regarding Violative Online Marketing

Sep 13, 2011

FDA?s Division of Drug Marketing, Advertising, and Communication (DDMAC) issued a letter to Pfizer?s vice-president of US Regulatory Affairs regarding its online resources page for Lipitor (atorvastatin calcium) tablets. The letter, which was brought about as part of the agency?s Bad Ad program, cites that the webpage is misleading because it makes representations and/or suggestions about the efficacy of Caduet (amlodipine besylate/atorvastatin calcium) tablets, Chantix (varenicline) tablets, and Norvasc (amlodipine besylate) tablets without communicating risk information associated with the use of these drugs.

USP and Brazil Partner on Public Health Education

Sep 6, 2011

The US Pharmacopeia (USP) continues to expand its collaboration with drug authorities around the world, this time with Brazil?s regulatory agency. USP and the Brazilian National Agency of Sanitary Surveillance (ANVISA) are teaming up to develop joint education activities for professionals involved in formulating and using pharmacopeial monograph standards in Brazil, according to news releases on the USP website.

Q&A with Francis S. Collins

Inside the National Institutes of Health
Sep 2, 2011

Inside the National Institutes of Health

China’s SFDA Following Through on GMP Efforts

Aug 23, 2011

Since China?s State Food and Drug Administration (SFDA) revised its GMPs last year (they became effective Mar. 1, 2011), the agency has been making other improvements to enhance the quality of its pharmaceutical manufacturing industry. Many improvements are tied to the 2015 deadline SFDA has placed on existing domestic drug manufacturers to implement the revised guidelines. Newly created companies are expected to meet the new GMPs from the start.

ADVERTISEMENT

ADVERTISEMENT

Click here