Tight Regulation Over Cigarettes: Got Approved

June 15, 2009

More than four decades after the surgeon general declared smoking a health hazard, the Senate on Thursday cleared the final hurdle to empowering federal officials to regulate cigarettes and other forms of tobacco for the first time.

The Congressional Budget Office has estimated the new law would reduce youth smoking by 11 percent and adult smoking by 2 percent over the next decade, in addition to reductions already achieved through other actions, like higher taxes and smoke-free indoor space laws.

Law gives power to FDA:

  • Law would give the F.D.A. power to set standards that could reduce nicotine content and regulate chemicals in cigarette smoke.
  • The law also bans most tobacco flavorings, which are considered a lure to first-time smokers.
  • The law would also tighten restrictions on the marketing and advertising of tobacco products.
  • Colorful ads and store displays will be replaced by black-and-white-only text.

Beginning next year, all outdoor advertising of tobacco within 1,000 feet of schools and playgrounds would be illegal.

What Cigarette Makers required to do:-

Cigarette makers will be required to stop using terms like “light” and “low tar” by next year and to place large, graphic health warnings on their packages by 2012.

Source: The New York Times


FDA revises ICH Q8 guidance

June 11, 2009

The FDA has revised its guidance on ICH Q8, adding an annex that clarifies the original document and adds the principles of quality by design (QbD).

The US Food and Drug Administration’s (FDA) guidance states that different drug delivery methods will have varying CQAs, such as adhesion properties for transdermal patches, but raw materials such as excipients and intermediates are common factors.

Using the framework devised by the International Conference on Harmonisation (ICH) the guidance details the importance of identifying CQAs and using knowledge of them to guide product and process development.

Source: in-pharmatechnologist


Vermont Gov. Jim Douglas signed a bill toughest controls in the country on financial relationships between doctors and industry

June 11, 2009

The bill imposes more restrictions on gifts from pharmaceutical and medical devicemaker firms to doctors, and demands more detailed financial disclosure of consulting and research contracts between the two parties.

Law Allow

The law does allow, however, for free drug samples; distribution of peer-reviewed academic, scientific or clinical articles or journals serving a true educational function; or financial support for med students, residents and fellows to attend educational or policymaking get-togethers.


Compliance trainings :FDA

June 4, 2009

Looking for FDA Compliance related training  then have look into following urls

All Trainings in FDA Compliance

  1. Successful FDA Pre-approval Inspections of Computer Systems
  2. The Pre-IND Process: Changes in Working with the FDA and Regulatory Procedures
  3. Auditing the QC Microbiology Laboratory for FDA Compliance
  4. What will FDA expect and request from your firm during Design Control portions of Inspections

Click here for more – ComplianceOnline


ISO 14971:2007

June 2, 2009

ISO 14971:2007 specifies a –

Process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.

The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.


Risk Evaluation and Mitigation Strategies (REMS) what you need to know in order to comply with FDA’s new requirements

June 1, 2009

What you need to know in order to comply with FDA’s new requirements :Risk Evaluation and Mitigation Strategies (REMS)

FDA compliance training will be valuable who are involved in the development of REMS and who are planning a submission and need to understand what might be required by FDA and how to comply and for those who have Risk Management Plans.

Learn here –

  • What is a REMS(Risk evaluation and mitigation strategies)?
  • What products are currently required to have a REMS(Risk evaluation and mitigation strategies)?
  • Where to start when writing a REMS(Risk evaluation and mitigation strategies)?
  • What department need to be involved in the preparation of a REMS(Risk evaluation and mitigation strategies)?
  • Without a REMS(Risk evaluation and mitigation strategies) guidance document …What format is FDA currently requiiring,?

Source: ComplianceOnline


FDA Warning Letters to Pharmaceutical Companies in 2009

May 28, 2009

fda_mast_01Warning Letters and Untitled Letters to Pharmaceutical Companies in 2009 here you will get the following information-


  1. Product/Issue
  2. Company/Individual
  3. Division/Office
  4. Released Date
  5. Posted Date

http://www.fda.gov/cder/warn/warn2009.htm