Regulations
The Lead
A Step Behind Globalization
June 11, 2012 9:26 am | by Ted Agres, Contributing Editor | Articles | Comments
The FDA lacks the capabilities necessary to ensure the safety of imported finished drugs and APIs used to manufacture drugs in the United States.
House GOP Releases Documents on Health Care Deals
June 1, 2012 8:53 am | by Ricardo Alonso-Zaldivar, Associated Press | News | Comments
The White House played political hardball with drug industry honchos to get a 2009 deal that...
Bigger Role. Bigger Target.
May 14, 2012 4:18 pm | by Ted Agres, Contributing Editor | Articles | Comments
Lawmakers are finalizing legislation to reauthorize the Prescription Drug User Fee Act , the...
One, Two, Three...
April 12, 2012 3:42 pm | by Ted Agres, Contributing Editor | Articles | Comments
The U.S. Food and Drug Administration has taken an important step in establishing the long-...
Questioning the Value of REMS
April 12, 2013 3:59 pm | by Ted Agres, Contributing Editor | Articles | CommentsThe U.S. Food and Drug Administration cannot determine whether its four-year-old Risk Evaluation and Mitigation Strategies program is working because drug companies have not provided key information when requested and the agency has not taken enforcement action against them.
Coming Up Short
April 12, 2013 9:54 am | by Peter Bennett, Editor | Articles | CommentsThe neverending din of partisan squabbling coming out of Washington can be deafening at times. Luckily for everyone, legislation like The Food and Drug Administration Safety and Innovation Act of 2012 seemed more or less immune to this cacophony, passing the Senate with 92 yay votes.
Glybera for the Treatment of Lipoprotein Lipase Deficiency
October 5, 2012 4:58 pm | by Carlos Camozzi, Vice President & Chief Medical Officer; uniQure, Amsterdam, Netherlands | Articles | CommentsIt has been a long and winding road for gene therapy, but on July 20, the European Medicines Agency recommended the approval of Glybera, a gene therapy for the treatment of lipoprotein lipase deficiency, a rare hereditary disorder, developed by uniQure.
Transporter Draft Guidance
March 21, 2012 6:33 pm | Articles | CommentsThe U.S. Food and Drug Administration published draft guidance entitled Drug Interaction Studies - Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations.
Grappling with "What If"
March 16, 2012 4:04 pm | by Ted Agres, Contributing Editor | Articles | CommentsWho, how, when, or even if. These are questions at the heart of the international debate over the genetic manipulation of the deadly H5N1 strain of bird flu to make it more transmissible.
Ensuring Quality for Container Closure Systems
March 13, 2012 2:45 pm | by Diane M. Paskiet, Associate Director, Scientific Affairs; West Pharmaceutical Services Inc., Lionville, Pa. | Articles | CommentsGMPs and other guidelines can help suppliers and pharmaceutical manufactures improve product quality, with greater efficiency and reliability.
A Guide to the Preserve Access to Affordable Generic Drugs Act
February 29, 2012 9:23 am | by GBI Research, London | Articles | CommentsThe Congressional Budget Office has analyzed a much-anticipated bill that bans pay-to-delay out-of-court settlements between pharmaceutical companies and generic drug makers. They estimated that the bill would result in savings of up to $5.2 billion for the government over the next 10 years.
FDA Adds New Safety Information to Statin Drugs
February 28, 2012 3:57 pm | News | CommentsThe Food and Drug Administration said it is making labeling changes to statins like Pfizer's Lipitor, AstraZeneca's Crestor and Merck & Co. Inc.'s Zocor.
Issues in the Characterization of Sub-Visible Particulates in Biologics
February 24, 2012 12:06 pm | Webinars | CommentsThis webinar discusses the methodologies used to characterize sub-visible particulates in parenterals, Dynamic Image Analysis for particulate characterization and orthogonal instrument methodologies.
Shine a Light on It
February 21, 2012 11:07 am | by Ted Agres, Contributing Editor | Articles | CommentsPharmaceutical companies that provide products covered by Medicare, Medicaid, or CHIP will be required to disclose to the federal government the name of any physician and researcher to whom a monetary payment "or other transfers of value" had been made.
Trimming the Fat
January 25, 2012 9:13 am | by Ted Agres, Contributing Editor | Articles | CommentsAs lawmakers continue to grapple with the nation’s burgeoning federal budget deficit, healthcare spending has moved into the cross-hairs of fiscal and legislative debate.
Pushing the Approval Pace
December 7, 2011 10:37 am | by Ted Agres, Contributing Editor | Articles | CommentsThe U.S. Food and Drug Administration will soon send Congress its recommendations for reauthorizing the Prescription Drug User Fee Act. The law allows the agency to hire additional staff to speed the review of applications for new drugs and biological products.
Answering 'What if...'
September 12, 2011 11:38 am | by Rita C. Peters, Editorial Director | Articles | CommentsSometimes, life can use a little excitement. Here in Northern New Jersey, we’ve had enough in the past week to last for a long time.
Follow-On-Biologics Framework: Overview and Comparisons
September 9, 2011 11:14 am | by Basil (Bill) J. Lewris, Partner, Linda A. Wadler, Partner; Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, D.C. | Articles | CommentsThe absence of an abbreviated U.S. Food and Drug Administration approval pathway for biologics was addressed in March 2010 when Congress passed the Biologics Price Competition and Innovation Act.
Nanotechnology, the Future, and the FDA
September 9, 2011 9:57 am | by Neil Canavan, Contributing Editor | Articles | CommentsDraft guidance released by the FDA is intended to provide stakeholders in the nanotechnology field with a framework with which they, and the agency, will construct a greater regulatory understanding. What are the potentials and pitfalls of this emerging technology?
What Works at What Cost?
August 1, 2011 12:30 pm | by Ted Agres, Contributing Editor | Articles | CommentsAs we prepare for increased use of comparative effectiveness research, a new study finds that only about half of the new drugs approved by the U.S. Food and Drug Administration during the past decade had CER data available from the manufacturer.
Hitting Leadoff in Biotech
July 13, 2011 6:40 am | by Emily Walsh, PhD, Principal Consultant; Halloran Consulting Group, Waltham, Mass. | Articles | CommentsOften heard advice for the entrepreneurial set is: “Be a credible threat.” That of course is a tall order. The odds and costs are stark. Historically, only 1 in 10 lead candidates make it through to approval, and this number is likely to be lower in 2010. If this weren’t daunting enough, the failure-inclusive cost of developing that one drug is thought to be a billion dollars.
FDA’s Five-Year Blueprint
June 3, 2011 12:23 pm | by Rita C. Peters, Editorial Director | Articles | CommentsStrategic plans are a lot like New Year’s resolutions. The creators have the best intentions, but implementing the plan may be another story.
Fixing the Crisis in Antibiotics
June 3, 2011 11:47 am | by Ted Agres, Contributing Editor | Articles | CommentsNature is winning the microbial battle against current antibiotics. Legislative and regulatory incentives may be needed to entice developers back into the fight.
Clearing a Path for Patents
May 9, 2011 8:56 am | by Ted Agres, Contributing Editor | Articles | CommentsAfter more than half a dozen years of wrangling, Congress is moving closer to approving the first major update to the U.S. patent system in nearly six decades.
Instruction Manual
September 15, 2010 7:26 am | by Ted Agres, Contributing Editor | Articles | CommentsBiosimilars now have a regulatory pathway, but are the directions to approval clear?
Cannabis in the Mainstream?
August 13, 2010 7:45 am | by Ted Agres, Contributing Editor | Articles | CommentsThe development of pharmaceuticals derived from cannabis took a major step forward in June when the UK’s Medicines and Healthcare Products Regulatory Agency approved the prescription use of Sativex to treat spasticity due to multiple sclerosis.
Unlocking hESC Success
May 18, 2010 10:00 am | by Ted Agres, Contributing Editor | Articles | CommentsIndustry-Academia collaborations may pay off with hESC-based drug screening advances.
Bioinsecurity
March 16, 2010 8:20 am | by Ted Agres, Contributing Editor | Articles | CommentsDebate continues within the government and scientific communities over how best to balance the often-competing interests of security and research freedom when it comes to potential bioterror pathogens such as Bacillus anthracis and Botulinum neurotoxins.
Conflicts of Interest
February 11, 2010 4:28 am | by Ted Agres, Contributing Editor | Articles | CommentsThe National Institutes of Health (NIH) has been stung in recent years by numerous reports of financial conflicts of interest involving staff scientists and drug, biotech, and medical device companies.
