Dear Friends, 

Please find attached an article which discusses the drug regulation and the establishment of therapeutic efficacy.

Kind regards, 

Attachments
 Drugregulation .pdf [238 KB] ::

Dear Friends, 

Please find attached an editorial on prescribing in pregnancy and lactation.

Kind regards, 

Attachments
 Prescribing.pdf [235 KB] ::

Dear Friends, 

Please find attached a very interesting article which gives the unreliability of equivalence trials. It was surprised to know that equivalence trials can even disprove solid clinical evidence such as the beneficial effect of thrombolytics in acute myocardial infarction.

Kind regards, 

Attachments
 Unreliability.pdf [366 KB] ::

Dear Friends,

Please find information on Retapamulin, a novel antibiotic and its mechanism of action.

Kind regards,

Attachments
 Retapamulin.pdf [633 KB] ::
 RetapamulinMOA.pdf [309 KB] ::

Dear Friends,

Please find an informative article on Ofatumumab.

Kind regards,

Attachments
 Ofatumumab.pdf [212 KB] ::

Dear Friends,

Please find informative news & analysis on 2009 FDA Approvals.

Kind regards,

Attachments
 2009FDAApprovals.pdf [293 KB] ::

Dear Friends,

The U.S. Food and Drug Administration today issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies.

The Bayesian statistical method applies an algorithm that makes it possible for companies to combine data collected in previous studies with data collected in a current trial. The combined data may provide sufficient justification for smaller or shorter clinical studies.

The FDA has substantial experience in the use of Bayesian statistical methods for the design and analysis of scientifically valid clinical studies. The FDA has approved a number of medical devices whose approval applications submitted to the FDA included clinical studies that used these statistical methods.

The final guidance, titled “Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials,” describes use of Bayesian methods, design and analysis of medical device clinical trials, the benefits and difficulties with the Bayesian approach, and comparisons with standard statistical methods. The guidance also presents ideas for using Bayesian methods in post-market studies.

The final document reflects public input gathered in 2006 after release of a draft of the guidance.

Health care payers are also contemplating the role Bayesian methods could play in making coverage decisions. In a June 2009 public meeting, the Medicare Evidence Development & Coverage Advisory Committee encouraged Medicare policymakers to consider Bayesian approaches when reviewing trials or technology assessments during the national coverage analysis process.

For this guidance click here.

Kind regards,

Dear Friends,

FDA issues revised ICH Guidance: "M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals."

Discusses the types of nonclinical studies, their scope and duration, and their relationship to the conduct of human clinical trials.

Federal Register listing: http://edocket.access.gpo.gov/2010/pdf/2010-1027.pdf

Guidance document: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM073246.pdf

Kind Regards,

Dear Friends,

The FDA recommended both Data Safety Monitoring Boards (DSMB) and Clinical Events Committees (CEC) be used for clinical trials examining replacement heart valves, in a draft guidance  issued Jan. 20. Click here for the Draft Guidance

The DSMB should establish criteria for recommending study termination for safety reasons before the study begins and should meet at least twice during the study to monitor adverse events, the agency recommended. The FDA said the DSMB should have members who are independent of the study sponsors and investigators and that two or more members should be physicians, including a cardiothoracic surgeon and a cardiologist. In addition, if the study includes statistical analyses, one DSMB member should be a statistician.

The Clinical Events Committee would adjudicate whether adverse events are valve-related and classify the severity of adverse events. Its members also should be independent of the study sponsors and investigators.

The guidance recommended that all study subjects be followed for at least one year. “If your clinical investigation is for one valve position, we recommend that you follow 300 or more subjects for one year or more for a total of 800 patient-years of follow-up.” If the study is for two valve positions, the agency recommended following 150 subjects for one year or more for each valve position for a total of 400 patient-years of follow-up per valve position.

The guidance said that “follow-up data should be collected for each subject until the entire study is terminated for all subjects.” The agency noted that as this follow-up period may be “significantly” longer than what is stated in the study protocol, and that the investigator must receive informed consent to such follow-up periods from all subjects.

Kind regards,

Dear Friends,

NICE is in the process of updating its clinical guideline on the management of chronic heart failure in adults and has published its draft recommendations for public consultation. Since the original guideline was published in 2003, new high-quality evidence from randomised controlled trials in diagnosis, treatment and monitoring have been published. This partial update will ensure that the recommendations take into account the new evidence available.

For the guideline click here.

Kind regards,

Dear Friends,

FDA has issued draft guidance on "IRB Continuing Review after Clinical Investigation Approval."  The guidance document is now available from FDA's website using the following web link:  http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM197347.pdf.

This draft guidance is intended to assist institutional review boards (IRBs) in carrying out their continuing review responsibility under 21 CFR 56.108(a) and 56.109(f) by providing recommendations regarding the criteria, process, and frequency of continuing review to assure the protection of the rights and welfare of subjects in clinical investigations.  The draft guidance should also help clinical investigators and sponsors better understand their responsibilities related to continuing review.  When finalized, this document will supersede the Information Sheet, Continuing Review After Study Approval (September 1998, Office of Health Affairs, Food and Drug Administration).

Kind regards,

Kind regards,

SreeRam

Proposed new regulations in China on the formulation and revision of national intellectual property (IP) standards involving patents contain several worrying provisions for IP holders, at least in the view of one expert observer.

The Standards Administration of China (SAC) issued the proposed regulations in November and has since been gathering public comments from a wide range of stakeholders. But, as currently worded, the draft regulations are "out of synch with the patent policies of international standards setting organisations and will negatively impact…innovation within China", George Willingmyre writes on Intellectual Property Watch's blog.

The author, president of standards and trade policy consultancy GTW Associates, highlights several proposals he sees of concern. For example, article nine of the SAC draft states that if an existing patent must be licensed to help implement a national standard, this will be done "at a price significantly lower than the normal royalties".

This is a condition not set by other major standards-setting bodies, and may discourage IP owners inside and outside China and impede the adoption of appropriate standards by China, Mr Willingmyre says in the blog (entries to which Intellectual Property Watch notes are solely those of the authors and are not associated with it).

He also points to article 13 of the SAC proposal, which outlines procedures for the compulsory licensing of patents. This says that, in principle, compulsory national standards shall not involve patents. But for those that do, patentees shall grant these free of charge. If agreement cannot be reached, the release of standards will be temporarily withheld or a compulsory licence granted according to law, it states.

"Compulsory licensing should be used rarely and in limited extraordinary circumstances" and within the global rules of the World Trade Organization's TRIPS agreement, Mr Willingmyre warns. The SAC would do well to consider co-ordinating its regulations in this area with other policy bodies in China, and laying out clearer guidelines which limit such licensing to critical extraordinary circumstances using well-defined criteria, he suggests.

China's State Council released a national IP strategy blueprint in 2008, which highlighted the need to significantly improve IP protection and enforcement to help drive the country's economic growth. It has since been moving to strengthen its patent laws, although major trading partners remain concern over whether these will be effectively enforced in practice.

Source: Scrip News

Dear Friends,

Please find an article on Good practice in the Post-Marketing Surveillance of Medicines.

Kind regards, 

Attachments
 Good Practice in the Postmarketing Surveillance of Medicines.pdf [33 KB] ::

Dear Friends,

Few things cause patients more fear and uncertainty than a cancer diagnosis. But today because of a steady stream of new and improved medicines and treatments—cancer increasingly can be managed and even beaten. America’s pharmaceutical research and biotechnology companies are responding. Pharmaceutical researchers are now working on 861 medicines for cancer. Many are high-tech weapons to fight the disease, while some involve innovative research on using existing medicines in new ways. The medicines in development—all in either clinical trials or under Food and Drug Administration review— include 122 for lung cancer, the leading cause of cancer death in the United States; 106 for breast cancer, which is expected to strike more than 180,000 American women each year; 103 for prostate cancer, which is expected to kill more than 28,000 American men each year; and 70 for colorectal cancer, the third most common cancer in both men and women in USA. Additional medicines target brain cancer, kidney cancer, leukemia, ovarian cancer, pancreatic cancer, skin cancer, and others. In addition, companies are working on medicines to improve the quality of life for cancer patients. America’s pharmaceutical research companies are working on many new cutting edge approaches to fight cancer. They include:

Click here for the complete report.

Kind regards,