Draft Guidance on Residual Solvents in Drug product

In continuation to the previous FDA letter to the industry, FDA issued a Draft Guidance “Residual Solvents in Drug Products”. PDF copy of the document attached here. Please note that, this guidance document is being distributed by FDA for comment purposes only.

 

 Vamshidhar

---

Subject: FDA announcement on Residula Solvents chapter <467>

 

Dear All,

 

FYI.

 

As you are aware, proposed Chapter from the U.S. Pharmacopeia (USP) for control of residual solvents in drug products will be effective from July 1, 2008. FDA announces that, all the drug substances, excipients, and products are subject to relevant control of residual solvents, even when no test is specified in the individual USP monograph.

 

The specifications for residual solvents in ANDAs should:

 

ü      Ensure that all drug substance and excipient components of the drug product, have residual solvent acceptance limits that fall within the ICH Q3C (option 1) limit

ü      Ensure that all drug substance and excipient components of the drug product, weighted by their amount in the drug product, results in a cumulative daily exposure for residual solvents that falls within the ICH Q3C (option 2) limit

ü      Ensure via direct testing of the drug product, that the total daily exposure for residual solvents falls within the ICH Q3C (option 2) limit.While the USP Chapter <467> specifically addresses drug products that are covered by a monograph in the USP, to assure safety of all products and for consistency of review, OGD also expects ANDAs for products not official in the USP to contain information and data as necessary that assures safe levels of residual solvents in the drug product consistent with USP <467>.

 

While the USP Chapter <467> specifically addresses drug products that are covered by a monograph in the USP, to assure safety of all products and for consistency of review, OGD also expects ANDAs for products not official in the USP to contain information on safe levels of residual solvents in the drug product consistent with USP <467>.

Teva to buy Barr Pharma for more than $7 billion

TRENTON, N.J. (AP) — Teva Pharmaceutical said Friday it will buy rival generic drugmaker Barr Pharmaceuticals for nearly $7.5 billion in a move that will boost Teva's dominance as the world's biggest generic drugmaker.

The deal continues consolidation of the generic-drug sector, driven by growth prospects as governments and other payers turn to the lower-priced medications and by the impending expiration of brand-name drug patents worth billions of dollars a year.

Israel-based Teva Pharmaceutical Industries Ltd. said acquiring Montvale, N.J.-based Barr Pharmaceuticals Inc., the world's No. 4 generic drug maker, will also expand its presence in U.S. and other key markets, from Russia to Eastern and Central Europe.

Analysts called the deal a great comination for both companies, and Barr shares jumped by double digits on the news.

"This was the 12th attempt to acquire Barr, and the third by Teva," Barr's chief executive, Bruce Downey, told analysts during a conference call. "This is the right price, the right time and the right opportunity."

Product launches by Teva in 2008

With a little curiosity of knowing the products that are launched by Teva Pharma this year, I've its opened the webpage.

There are total 22 launches in US market. I feel this is a big number for any generic company. I still remember, the maximum number of approvals my previous company got in an year was 14...not all of them are product launches..some of them are Tentative approvals.

Probably, thats what makes Teva #1 Generic firm.

 

cGMPs 2008_FDA/Industry Summer Workshop_$500

This is about a workshop sponsored by Consumer Healthcare Products Association on the latest developments concerning quality initiatives for pharmaceutical compliance on August 4, 2008, Chicago, Illinois.

 

What is this workshop about?

The FDA/Industry Workshop is an extraordinary, one-day educational event for the agency and its regulated pharmaceutical industries. For three decades, this annual workshop has provided a forum for face-to-face, in-depth discussion on topical issues and processes to increase compliance and improve the utilization of resources. The goal, shared by regulator and industry alike, is to ensure the continued availability of high-quality drug products.

 

Why should you attend?

Whether you are an FDA official or an industry professional, the agency’s science- and risk-based approach to cGMPs affects all aspects of the production of safe and effective drug products. Co-sponsored by FDA and established to bring together industry and agency officials, this workshop is designed to ensure the primary players in pharmaceutical quality fully understand the evolution of the cGMP process and its potential implications in effective program management. Over the course of the day-long workshop, FDA officials will explain the process in detail and industry presenters will explain the practical application of each issue. In interactive sessions, participants will be encouraged to ask direct questions and provide feedback. This is a unique opportunity for both FDA and industry to get a comprehensive understanding of the quality processes guiding their work.

 

When and where is the workshop?

August 4, 2008

Hyatt Regency Chicago

151 East Wacker Drive

Chicago, IL 60601

Tel: 800.233.1234 | Fax: 312.565.2966

 

For complete details and program overview you may refer to the attachment.

Providing Regulatory Submissions in e-format_Drug Listing

The Food and Drug Administration announced in a Federal Register notice of July 11, 2008, the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing.'' This draft guidance document establishes a Pilot Program for industry to voluntarily submit drug establishment registration and drug listing information in an electronic format that FDA can process, review, and archive. The document provides guidance on what required and FDA-recommended information related to drug establishment registration and drug listing to submit and on how to electronically prepare and submit the information to FDA http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-15801.pdf and http://www.fda.gov/OHRMS/DOCKETS/98fr/FDA-2005-N-0464-gdl.pdf.

List of Authorized Generic Drugs

List of Authorized Generic Drugs

• List of Authorized Generic Drugs
• Background Information
• What Is an Authorized Generic Drug?
• How to Contact Us

Background Information

On September 27, 2007, the President signed into law the Food and Drug Administration Amendments Act (FDAAA) (Public Law 110-85).  Among other things, FDAAA added new subsection (t) to section 505 of the Federal Food, Drug, and Cosmetic Act (the Act).   Section 505(t) is titled “Database For Authorized Generic Drugs,” and requires that FDA publish a complete list on its Internet site of all authorized generic drugs, including(1) the drug trade name, (2) the brand company manufacturer, and (3) the date the authorized generic drug entered the market.  The agency is required to update the list quarterly.  Section 505(t)(2) of the Act requires the list to contain authorized generic drugs included in an annual report submitted to the agency after January 1, 1999.

What Is an Authorized Generic Drug?

An “authorized generic drug” is a listed drug as defined in § 314.3 that has been approved under subsection 505(c) of the act and is marketed, sold, or distributed directly or indirectly to retail class of trade with either labeling, packaging (other than repackaging as the listed drug in blister packs, unit doses, or similar packaging for use in institutions), product code, labeler code, trade name, or trade mark that differs from that of the listed drug.

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How to Contact Us

You may e-mail questions about the List of Authorized Generics Drugs to:
AuthorizedGenerics@fda.hhs.gov

The 10 Biggest Minutes of Your Interview

Courtesy: msn.com

The 10 Biggest Minutes of Your Interview

Why the first 10 minutes of your interview can make or break you and how you can prepare.

By Joe Turner, Career Coach

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You've heard it said often: "First impressions are the most important."

When it comes to the job interview, here's recent proof that bears this out: 

"Hiring managers often know whether they might hire someone soon after the opening handshake and small talk," a new survey suggests. Executives polled said it takes them just 10 minutes to form an opinion of job seekers, despite meeting with staff-level applicants for 55 minutes and management-level candidates for 86 minutes, on average.  Executives were asked, "How long does it typically take you to form either a positive or negative opinion of a job candidate during an initial interview?"  The mean response was 10 minutes.*

This came from a survey published April 12, 2007, and developed by Robert Half Finance & Accounting, the largest specialized financial recruitment service in the world. It included responses from 150 senior executives with Fortune 1000 companies.

So what does this mean for you as you approach job interviews?

Max Messmer, chairman and CEO of Robert Half International, sums it up when he says,  "The interview begins the moment job seekers arrive, so applicants need to project enthusiasm and confidence from the start. The opening minutes of the conversation often set the tone for the rest of the discussion, making it wise to prepare especially well for the first few interview questions."

Here's how to make the first 10 minutes of your interview work in your favor:

1. Know the four most important questions

Pay close attention to those four most important questions they want answers to:

1. Why are you here?


2. What can you do for us?


3. Will you fit in? (Will you get along with our values and culture here?)


4. What makes you different from everyone else that we may have talked with? (Will you go that extra mile?)

Rehearse your answers with your own personal "stories."  These are short narratives describing times when you overcame a crisis, led a team, met a deadline, resurrected a failed project, etc.  

Some common questions you'll often encounter at the beginning of the interview:

"Tell me a little about yourself." (Question #2: "What can you do for us?")

"What do you know about us?" (Question #1: "Why are you here?")

"Why are you here today?" (Same)

"Why are you looking to change jobs?" (Question#2: "What can you do for us?")

"What's your most important accomplishment to date?" (Same)

Why should we hire you (over everyone else we've seen)? (Question #4: "Will you go the extra mile?")

2. Know the company

Do your homework.  Always research the company before you interview.  Know who they are, what they do, what their major products and services are, who their competitors are and the current "buzz" about them.

Here's why:

The first few minutes of the interview are the time to flatter them.  Remember the question, "Why are you here?"  Show them that you've done your research and not only know something about their company, but also have several reasons for being enthusiastic about working for them.  Let this enthusiasm carry over into your demeanor as you walk in the door. 

3. Know your role

First impressions count for a lot, especially in the job interview.  You're on stage from the minute you enter the room.  So play your role by first getting into character:

The "character" you play is that of a problem solver, not a job seeker.

As a problem solver, you know why you are here, you're excited about this company, and you know you can help them achieve their goals. With this kind of ammunition, you can score direct hits on their opening questions and win big points for yourself by demonstrating you are both knowledgeable and excited about their opportunity.

Now have a killer interview!

As a recruiter, Joe Turner has spent the past 15 years finding and placing top candidates in some of the best jobs of their careers.  Author of "Job Search Secrets Unlocked," Turner has been interviewed on radio talk shows and offers free insider job search secrets at: http://www.jobchangesecrets.com.