Should we start getting worried?

[anonymous]

I am hearing that it will now most likely be Q4.

 

[anonymous]

I am hearing that it will now most likely be Q4.

We are supposed to hang around waiting for a year?

 

[anonymous]

I am hearing that it will now most likely be Q4.

i was told Q2 May/june time frame

 

[anonymous]

i was told Q2 May/june time frame

That is old news. More like end of Q4.

 

[anonymous]

That is old news. More like end of Q4.

I was told q2 sometime too

 

[anonymous]

I was told q2 sometime too

I was just told a May/June start date... seeing is believing at this point.

 

[anonymous]

I was just told a May/June start date... seeing is believing at this point.

Coin flip at this point?

 

[anonymous]

Coin flip at this point?

It will happen just a matter of when. Got letter from HR says may/June. Will see!

 

[anonymous]

Might see the launch by end of year.

 

[anonymous]

Might see the launch by end of year.

Heard the same thing this afternoon.

 

[anonymous]

Heard the same thing this afternoon.

From whom? Last memo was sent out 2 weeks ago moving launch to middle or end of q2, which is may/June, that's the only official update

 

[anonymous]

From whom? Last memo was sent out 2 weeks ago moving launch to middle or end of q2, which is may/June, that's the only official update

Received a call stating that the drug needs to go through the FDA advisory panel. Believe me not the news I want to share as I was very excited and hopeful for a May/June start. At this point maybe a launch Q4... but who launches in the 4th quarter. Any one else hearing from their hiring manager or HR with these dates?

 

[anonymous]

Received a call stating that the drug needs to go through the FDA advisory panel. Believe me not the news I want to share as I was very excited and hopeful for a May/June start. At this point maybe a launch Q4... but who launches in the 4th quarter. Any one else hearing from their hiring manager or HR with these dates?

I heard may/June through HR letter as well, but here is some of what is happening with FDA as they try to get a handle on opioid abuse epidemic.

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The FDA is deeply concerned about the growing epidemic of opioid abuse, dependence and overdose in the United States. In response to this crisis, the agency has developed a comprehensive action plan to take concrete steps toward reducing the impact of opioid abuse on American families and communities. As part of this plan, the agency is committing to work more closely with its advisory committees before making critical product and labeling decisions; enhancing safety labeling; requiring new data; and seeking to improve treatment of both addiction and pain. At the same time, the FDA will fundamentally re-examine the risk-benefit paradigm for opioids and ensure that the agency considers the wider public health effects. The FDA is committed to taking all of these steps transparently and in close cooperation with its sister agencies and stakeholders.

The FDA’s actions include:

• Expand use of advisory committees. Starting today, the FDA will convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties. And the Pediatric Advisory Committee will make recommendations regarding a framework for pediatric opioid labeling before any new labeling is approved. The FDA will consult an advisory committee on abuse-deterrent formulation (ADF) opioids when they raise novel issues. Outcome: Review and advice from external experts with opportunity for public input before approval of any new opioid that does not have abuse-deterrent properties and expert advice on pediatric opioid labeling.
• Develop warnings and safety information for immediate-release (IR) opioid labeling. The FDA is developing changes to IR opioid labeling, including additional warnings and safety information that incorporate elements similar to the extended-release/long-acting (ER/LA) opioid analgesics labeling update that occurred in 2013. Outcome: Better information for doctors about the risks and how to prescribe safely.
• Strengthen postmarket requirements. Because the evidence base to guide the use of opioid medications, particularly in the setting of long-term use, is substantially lacking, the FDA is strengthening the requirements for drug companies to generate postmarket data on the long-term impact of using ER/LA opioids. Outcome: Better evidence on the serious risks of misuse and abuse associated with long-term use of opioids, predictors of opioid addiction and other important issues.
• Update Risk Evaluation and Mitigation Strategy (REMS) Program. ER/LA opioids are currently subject to a REMS program that requires sponsors to fund continuing medical education (CME) providers to offer, at low or no cost, CME courses on the appropriate use of these products. The FDA will update the REMS program requirements for opioids after considering advisory committee recommendations and review of existing requirements. Outcome: Increase the number of prescribers who receive training on pain management and safe prescribing of opioid drugs in order to decrease inappropriate opioid prescribing.
• Expand access to abuse-deterrent formulations (ADFs) to discourage abuse. The pharmaceutical industry has shown significant interest in developing ADFs and the technology is progressing rapidly. ADFs hold promise as their abuse-deterrent qualities continue to improve and as they become more widely available. The FDA will issue draft guidance with its recommendations for the approval standards for generic abuse-deterrent formulations. Release of this guidance is a high priority, since the availability of less costly generic products should accelerate prescribers’ uptake of ADFs. Outcome: Spur innovation and generic ADF product development.
• Support better treatment. The FDA is reviewing options, including over-the-counter availability, to make naloxone more accessible to treat opioid overdose, building on the agency’s recent approval of intranasal naloxone. The agency actively supports the Centers for Disease Control and Prevention guidelines for prescribing opioids for the treatment of pain and will facilitate the development of evidence and improved treatments. Outcome: Broader access to overdose treatment, safer prescribing and use of opioids, and ultimately, new classes of pain medicines without the same risks as opioids.
• Reassess the risk-benefit approval framework for opioid use. The FDA will seek advice from the agency’s Science Board in March 2016 and is already engaging the National Academies of Sciences, Engineering, and Medicine on how to take into account our evolving understanding of the risks of opioids, not only to the patient but also the risks of misuse by other persons who obtain them. These reports will be publicly available. Outcome: Formal incorporation of the broader public health impact of opioid abuse in approval decisions.

Fact Sheet – FDA Opioids Action Plan PDF

Press Release: Califf, FDA top officials call for sweeping review of agency opioids policies


More in Fact Sheets
Page Last Updated: 02/05/2016
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[anonymous]

Received a call stating that the drug needs to go through the FDA advisory panel. Believe me not the news I want to share as I was very excited and hopeful for a May/June start. At this point maybe a launch Q4... but who launches in the 4th quarter. Any one else hearing from their hiring manager or HR with these dates?

I hear may/June from HR as well. This may shed some light on what the FDA is doing to try to crack down on opioid epidemic which is clearly having an impact on all drugs going through approval process.

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FDA
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Search FDA

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The FDA is deeply concerned about the growing epidemic of opioid abuse, dependence and overdose in the United States. In response to this crisis, the agency has developed a comprehensive action plan to take concrete steps toward reducing the impact of opioid abuse on American families and communities. As part of this plan, the agency is committing to work more closely with its advisory committees before making critical product and labeling decisions; enhancing safety labeling; requiring new data; and seeking to improve treatment of both addiction and pain. At the same time, the FDA will fundamentally re-examine the risk-benefit paradigm for opioids and ensure that the agency considers the wider public health effects. The FDA is committed to taking all of these steps transparently and in close cooperation with its sister agencies and stakeholders.

The FDA’s actions include:

• Expand use of advisory committees. Starting today, the FDA will convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties. And the Pediatric Advisory Committee will make recommendations regarding a framework for pediatric opioid labeling before any new labeling is approved. The FDA will consult an advisory committee on abuse-deterrent formulation (ADF) opioids when they raise novel issues. Outcome: Review and advice from external experts with opportunity for public input before approval of any new opioid that does not have abuse-deterrent properties and expert advice on pediatric opioid labeling.
• Develop warnings and safety information for immediate-release (IR) opioid labeling. The FDA is developing changes to IR opioid labeling, including additional warnings and safety information that incorporate elements similar to the extended-release/long-acting (ER/LA) opioid analgesics labeling update that occurred in 2013. Outcome: Better information for doctors about the risks and how to prescribe safely.
• Strengthen postmarket requirements. Because the evidence base to guide the use of opioid medications, particularly in the setting of long-term use, is substantially lacking, the FDA is strengthening the requirements for drug companies to generate postmarket data on the long-term impact of using ER/LA opioids. Outcome: Better evidence on the serious risks of misuse and abuse associated with long-term use of opioids, predictors of opioid addiction and other important issues.
• Update Risk Evaluation and Mitigation Strategy (REMS) Program. ER/LA opioids are currently subject to a REMS program that requires sponsors to fund continuing medical education (CME) providers to offer, at low or no cost, CME courses on the appropriate use of these products. The FDA will update the REMS program requirements for opioids after considering advisory committee recommendations and review of existing requirements. Outcome: Increase the number of prescribers who receive training on pain management and safe prescribing of opioid drugs in order to decrease inappropriate opioid prescribing.
• Expand access to abuse-deterrent formulations (ADFs) to discourage abuse. The pharmaceutical industry has shown significant interest in developing ADFs and the technology is progressing rapidly. ADFs hold promise as their abuse-deterrent qualities continue to improve and as they become more widely available. The FDA will issue draft guidance with its recommendations for the approval standards for generic abuse-deterrent formulations. Release of this guidance is a high priority, since the availability of less costly generic products should accelerate prescribers’ uptake of ADFs. Outcome: Spur innovation and generic ADF product development.
• Support better treatment. The FDA is reviewing options, including over-the-counter availability, to make naloxone more accessible to treat opioid overdose, building on the agency’s recent approval of intranasal naloxone. The agency actively supports the Centers for Disease Control and Prevention guidelines for prescribing opioids for the treatment of pain and will facilitate the development of evidence and improved treatments. Outcome: Broader access to overdose treatment, safer prescribing and use of opioids, and ultimately, new classes of pain medicines without the same risks as opioids.
• Reassess the risk-benefit approval framework for opioid use. The FDA will seek advice from the agency’s Science Board in March 2016 and is already engaging the National Academies of Sciences, Engineering, and Medicine on how to take into account our evolving understanding of the risks of opioids, not only to the patient but also the risks of misuse by other persons who obtain them. These reports will be publicly available. Outcome: Formal incorporation of the broader public health impact of opioid abuse in approval decisions.

Fact Sheet – FDA Opioids Action Plan PDF

Press Release: Califf, FDA top officials call for sweeping review of agency opioids policies


More in Fact Sheets
Page Last Updated: 02/05/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

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U.S. Food and Drug Administration
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Silver Spring, MD 20993
1-888-INFO-FDA (1-888-463-6332)
Contact FDA
Subscribe to FDA RSS feeds Follow FDA on Twitter Follow FDA on Facebook View FDA videos on YouTube View FDA photos on Flickr
Scroll back to top

 

[anonymous]

I hear may/June from HR as well. This may shed some light on what the FDA is doing to try to crack down on opioid epidemic which is clearly having an impact on all drugs going through approval process.

When did you hear May/June time frame though? I was told that the advisory panel will meet over the summer and then at that point they will decide to approve or not. I heard this from hiring manager and not HR.

• Skip to main page content

FDA
U.S. Food and Drug Administration
Search FDA

• Popular Content

• Fact Sheets

SHARE

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The FDA is deeply concerned about the growing epidemic of opioid abuse, dependence and overdose in the United States. In response to this crisis, the agency has developed a comprehensive action plan to take concrete steps toward reducing the impact of opioid abuse on American families and communities. As part of this plan, the agency is committing to work more closely with its advisory committees before making critical product and labeling decisions; enhancing safety labeling; requiring new data; and seeking to improve treatment of both addiction and pain. At the same time, the FDA will fundamentally re-examine the risk-benefit paradigm for opioids and ensure that the agency considers the wider public health effects. The FDA is committed to taking all of these steps transparently and in close cooperation with its sister agencies and stakeholders.

The FDA’s actions include:

• Expand use of advisory committees. Starting today, the FDA will convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties. And the Pediatric Advisory Committee will make recommendations regarding a framework for pediatric opioid labeling before any new labeling is approved. The FDA will consult an advisory committee on abuse-deterrent formulation (ADF) opioids when they raise novel issues. Outcome: Review and advice from external experts with opportunity for public input before approval of any new opioid that does not have abuse-deterrent properties and expert advice on pediatric opioid labeling.
• Develop warnings and safety information for immediate-release (IR) opioid labeling. The FDA is developing changes to IR opioid labeling, including additional warnings and safety information that incorporate elements similar to the extended-release/long-acting (ER/LA) opioid analgesics labeling update that occurred in 2013. Outcome: Better information for doctors about the risks and how to prescribe safely.
• Strengthen postmarket requirements. Because the evidence base to guide the use of opioid medications, particularly in the setting of long-term use, is substantially lacking, the FDA is strengthening the requirements for drug companies to generate postmarket data on the long-term impact of using ER/LA opioids. Outcome: Better evidence on the serious risks of misuse and abuse associated with long-term use of opioids, predictors of opioid addiction and other important issues.
• Update Risk Evaluation and Mitigation Strategy (REMS) Program. ER/LA opioids are currently subject to a REMS program that requires sponsors to fund continuing medical education (CME) providers to offer, at low or no cost, CME courses on the appropriate use of these products. The FDA will update the REMS program requirements for opioids after considering advisory committee recommendations and review of existing requirements. Outcome: Increase the number of prescribers who receive training on pain management and safe prescribing of opioid drugs in order to decrease inappropriate opioid prescribing.
• Expand access to abuse-deterrent formulations (ADFs) to discourage abuse. The pharmaceutical industry has shown significant interest in developing ADFs and the technology is progressing rapidly. ADFs hold promise as their abuse-deterrent qualities continue to improve and as they become more widely available. The FDA will issue draft guidance with its recommendations for the approval standards for generic abuse-deterrent formulations. Release of this guidance is a high priority, since the availability of less costly generic products should accelerate prescribers’ uptake of ADFs. Outcome: Spur innovation and generic ADF product development.
• Support better treatment. The FDA is reviewing options, including over-the-counter availability, to make naloxone more accessible to treat opioid overdose, building on the agency’s recent approval of intranasal naloxone. The agency actively supports the Centers for Disease Control and Prevention guidelines for prescribing opioids for the treatment of pain and will facilitate the development of evidence and improved treatments. Outcome: Broader access to overdose treatment, safer prescribing and use of opioids, and ultimately, new classes of pain medicines without the same risks as opioids.
• Reassess the risk-benefit approval framework for opioid use. The FDA will seek advice from the agency’s Science Board in March 2016 and is already engaging the National Academies of Sciences, Engineering, and Medicine on how to take into account our evolving understanding of the risks of opioids, not only to the patient but also the risks of misuse by other persons who obtain them. These reports will be publicly available. Outcome: Formal incorporation of the broader public health impact of opioid abuse in approval decisions.

Fact Sheet – FDA Opioids Action Plan PDF

Press Release: Califf, FDA top officials call for sweeping review of agency opioids policies


More in Fact Sheets
Page Last Updated: 02/05/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

• Accessibility
• Website Policies

U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
1-888-INFO-FDA (1-888-463-6332)
Contact FDA
Subscribe to FDA RSS feeds Follow FDA on Twitter Follow FDA on Facebook View FDA videos on YouTube View FDA photos on Flickr
Scroll back to top

 

[anonymous]

It will happen just a matter of when. Got letter from HR says may/June. Will see!

When did you receive this letter? I got a call saying MAYBE Q4, if at all. I was told that it will be reviewed over the summer just 2 days ago.

 

[anonymous]

When did you receive this letter? I got a call saying MAYBE Q4, if at all. I was told that it will be reviewed over the summer just 2 days ago.

A couple weeks ago.
Who called you and told you maybe Q4 if at all?
I think a letter from HR is the most credible source.

 

[anonymous]

A couple weeks ago.
Who called you and told you maybe Q4 if at all?
I think a letter from HR is the most credible source.

I am hearing Q4 at the earliest.

 

[anonymous]

Only sorry ass reject reps with no self worth or options would sit around for this. You're already the laughing stock of the industry and haven't launched yet. You fools think it's the article listed above. You have no clue and that's why you are where you are losers

 

[anonymous]

I am hearing Q4 at the earliest.

You are full of it! If you didn't get a letter from HR than you don't know crap! Those who were hired with contingent offers got letters. You are just spouting rumors which have no credibility and you are just making this stuff up.