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Recent Food And Drug Administration Fda Inquiries

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Food And Drug Administration (fda)

Hi zintro expert, the zintro blog needs you! we are looking for expert opinions on the news mentioned below and would like to include your point of view. We realize your time is valuable, so here is a brief summary of what we are looking for: *a brief answer to the prompt about 1-2 paragraphs including your full name *participation is voluntary no payment will be involved *if chosen, you will be named in the post and we'll include a link to your zintro profile which will generate more visitors for you topic and prompt the fda issued new guidance that aims to clarify whether a change in a medical device may require a recall – or is simply an “enhancement.” according to a notice published last week in the federal register, companies may have trouble determining whether an update to their product meets the criteria for a recall. The guidance formally defines an enhancement and presents a q-and-a as well as sample scenarios to illustrate its recommendations. “it will make the process of determining whether a modification is an enhancement that much clearer, and companies can proceed with more confidence that they’re doing the right thing,” said jeffrey secunda, vice president of technology and regulatory at advanced medical technology association (advamed), a medical device trade group. According to fda, an “enhancement” is a change that improves the quality of the device — something that makes the device better meet the consumer’s needs — but it is not something that remedies a violation of the federal food, drug and cosmetic act. What are your thoughts? Getting your name and expert opinion published on our blog is a great marketing opportunity. If interested, please send a response to the prompt via znotes within 1-2 days. Don't forget to include your full name. If you have any questions, please let us know. Thank you! the zintro blog team wondering what the post would look like? Here is a sample: http://blog.Zintro.Com/2014/08/14/rosetta-completes-10-year-trip-deep-space />

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    Luis |President

    I would like to ***** the interview....

    21 Minutes Later
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    DANIEL |CEO

    Daniel O'Connell President Prometheus Medical Medical Device Consultants The meaning of this is t...

    10 Hours Later
+2 Other Responses
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Fda Filing

Need an expert in regulatory filings to fda on generics. Questions are around what changes to an anda require a new filing vs. An amendment. Examples are changing dmf source or api supplier, and changing formulation for injectable drug from powder to lyo or vice versa.

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    Aloysius |President

    BREEJ Technologies Consulting Group offers Consulting Services to the Pharmaceutical Industry. As P...

    1.2 Hours Later
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    Timothy |Principal

    I am a former FDA Review Chemist, with > 30 years of career experience in pharmaceutical R&D, Qualit...

    1.5 Hours Later
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    Jai |Zintro Expert

    I can help with these types of issues with ANDAs. I have developed, filed and obtained approvals on...

    1 Day Later
+11 Other Responses
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Drug Regulatory System

Hello , looking for expert views for drug regulatory custom projects -is dissolution required (solid oral dosage forms) of local innovator vs canadian reference product vs generic product? (how many time points, phs and number of vessels are required? Do all strengths need to go undergo dissolution testing)? -bulk stability required? -is a commercial stability commitment required? If yes, please specify. -is one dossier required per strength? -is there a policy on intellectual property in the country of submission? More specifically how is the earliest generic submission date determined? -stability data required – number of batches per strength? (zone ii or zone iv stability studies required, accelerated stability? How many batches per api supplier are needed?) -is local labeling required or special label requirement? -are there any limitations of the number of api suppliers/ finished product manufacturers/ packaging sites? -are there any limitations on the location of the sites (eg. Is a manufacturing site in india acceptable?); is local manufacturing required by law (manufacturing need to take place locally in order to obtain marketing authorization)? -is local be/ba study required (local reference product/local population)? -any specific accreditation/certification of the cro and biolab required? Many thanks in advance great regards alex

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    steve |ceo

    Great questions Alex, we answer these CMC and IP issues regularly. Contact me and we can quickly ans...

    57 Minutes Later
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    Majid |President

    Hello, I have done Bioequivalence testing for Pharma and I am very familiar with requirement. Plea...

    1.2 Hours Later
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    Timothy |Principal

    I am a former FDA Review Chemist, with > 30 years of career experience in pharmaceutical R&D, Qualit...

    1.3 Hours Later
+7 Other Responses
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Generic Drug

I need help with fda approval process for generic drugs

    +undefined Other Responses
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    Bioanalytical Sciences, Drug Metabolism,

    We are looking for experts (one in human drug metabolism and one in animal and human toxicology) to provide summary reviews of the extant literature on two active ingredients, which will be disclosed after a cda is signed. These are oral active agents, with one in rx use for decades and another for food use for a number of years. There is considerable published literature on each active. The review would inform the project team about possible pharm/tox and metabolic studies needed in support of a 505(b)(2) application, as well as the summary write-up for the ind application. Respondents to this search should have hands-on experience in rx drug development and an understanding of fda requirements for drug approval.

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      Jeffrey |President and Managing Director

      I am an MD/PhD basic and clinical pharmacologist with more than 30 years of drug development experie...

      27 Minutes Later
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      May D. |Director

      I am very interested in this project. I am a recently retired bioanalytical, DM/PK R&D scientist wit...

      30 Minutes Later
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      Michael |Principal

      I would be happy to discuss your needs. I have extensive experience in toxicology and ADME studies,...

      2.5 Hours Later
    +14 Other Responses
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    Food Packaging Chemicals

    Hi zintro expert, the zintro blog needs you! we are looking for expert opinions on the news mentioned below and would like to include your point of view. We realize your time is valuable, so here is a brief summary of what we are looking for: *a brief answer to the prompt about 1-2 paragraphs including your full name *participation is voluntary no payment will be involved *if chosen, you will be named in the post and we'll include a link to your zintro profile which will generate more visitors for you topic and prompt nine consumer and environmental health groups petitioned the food and drug administration this week seeking a ban on the use of certain chemicals in food packaging. The petitions target perchlorate, which is added to sealing gaskets for food containers and to reduce static in dry food packaging, and a family of chemicals known as long-chain perfluorocarboxylates (pfcs) that keep grease out of paper and paperboard, such as pizza boxes and sandwich wrappers. These chemicals have the potential to harm fetal development, male reproductive systems, pre- and post-natal brain development and cause cancer, stated the petition signatories. The perchlorate petition stemmed, in part, from data nrdc received from a freedom of information act request for scientific assessments fda used to grant approval for the chemical’s use in 2005. The groups argue that the agency’s data were flawed. What are your thoughts? Getting your name and expert opinion published on our blog is a great marketing opportunity. If interested, please send a response to the prompt via znotes within 1-2 days. Don't forget to include your full name. If you have any questions, please let us know. Thank you! the zintro blog team wondering what the post would look like? Here is a sample: http://blog.Zintro.Com/2014/08/14/rosetta-completes-10-year-trip-deep-space

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      Rajkumar |Pharmaceutical Consultant

      The petitioners claim on harmful effects of long-chain perfluorocarboxylates (PFCs) shall be evalu...

      16 Hours Later
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      Richard |President, VP, Director, Research Engine

      One should consider the use of Polyhydroxyalkonates (PHA) Biopolymers as a solution as they offer e...

      2 Days Later
    +2 Other Responses
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    Food Fda Approval

    We are looking to make a salsa from our family recipe. We were told we need to have a food technologist formulate a recipe for fda approval. Please advise.

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      Jack |President

      A great deal depends upon exactly what you want to make, how you want to process it and how much you...

      7 Minutes Later
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      Mukund |President

      I am an expert in salsa. I also make my salsa for the retail. Let me know how I can help you. My fee...

      7 Minutes Later
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      Andres |CEO

      Actually what is the question? Are you looking for a food technologist? Are you looking for a sauce ...

      2.6 Hours Later
    +10 Other Responses
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    Fda Compliance Witness

    Need to locate expert witness on short notice to opine that otc drug label is fda-compliant.

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      Karen |Owner/Principal Consultant.......formerl

      Former FDA Medical Officer not a consultant to industry...

      14 Minutes Later
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      Les |Principal

      Please let me know some specifics so that I can *****ond to your inquiry. Thanks,...

      33 Minutes Later
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      Michael |Senior Principal Consultant

      How much will I be involved (hours and rate)? Please advise. Michael Zhou...

      4.3 Hours Later
    +4 Other Responses
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    Lab Planner For Food And Drug Qc

    We need a lab planner not less than 20 years experience for quality control food and drug lab project, the consultation will include three visit, each visit not less than 5 days

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      medhat |labs director

      yes i can give a hand of help in this matter ...

      1.7 Hours Later
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      Julia |Sr

      I could help...

      16.7 Hours Later
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      John |Research Chemist

      I've designed and built several labs, including food safety, and I've worked in biopharma QC labs....

      1.2 Days Later
    +6 Other Responses
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    3d Printed Drug

    Hi zintro expert, the zintro blog needs you! we are looking for expert opinions on the news mentioned below and would like to include your point of view. We realize your time is valuable, so here is a brief summary of what we are looking for: *a brief answer to the prompt about 1-2 paragraphs including your full name *participation is voluntary no payment will be involved *if chosen, you will be named in the post and we'll include a link to your zintro profile which will generate more visitors for you topic and prompt this week the us food and drug administration (fda) gave the go ahead to the first 3d-printed drug, spritam, which is designed to treat seizures brought on by epilepsy in adults and children. It was developed using zipdose, a 3d printer that creates ills by printing out thin layers of medicine in powder form, with layers of a water-based binder spread between each of the powder layers. The result is a tablet that can dissolve with a sip of water in less than five seconds. Spritam will be commercially available from early 2016 onwards. Do you think 3d-printed drugs could have the ability to transform the pharmaceuticals industry. Getting your name and expert opinion published on our blog is a great marketing opportunity. If interested, please send a response to the prompt via znotes within 1-2 days. Don't forget to include your full name. If you have any questions, please let us know. Thank you! the zintro blog team wondering what the post would look like? Here is a sample: http://blog.Zintro.Com/2014/08/14/rosetta-completes-10-year-trip-deep-space />

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      paul |CEO management - sales - marketing - des

      I need to see the actual process before I make a comment, my initial response is the speed of produc...

      3.2 Hours Later
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      Jorge Horacio |CEO

      I think that this technology will be welcome, it is an advance over the actual systems of drug deliv...

      22.9 Hours Later
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      Scott |Vice President/Partner

      The evolvement of technology into healthcare is rapidly changing every component of medicine. It is...

      19.5 Days Later
    +3 Other Responses
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    Dyslipidemia Drugs

    We are looking for us regulatory experts who have experience/knowledge in dealing with dyslipidemia drugs and their approval and market launch via fda.

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      Anastasia |Consultant-Microbiologist

      My expertise is in the CMC microbiology section of NDA and BLA submissions. Most of these drugs are ...

      1.2 Days Later
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      Marc |Chief Development Officer

      Can you describe your specific interests regarding *****ledge and dyslipidemic drugs? We ...

      22.2 Days Later
    +2 Other Responses
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    Fda Recall

    Our law firm represents a physician in a suit in texas arising out of a drug manufacturer product recall. We are looking for an expert consultant on fda recall issues to assist us and to potentially testify at trial.

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      Jim |Founder & President

      I have experience with drug recalls and would be interested in speaking with you....

      4 Minutes Later
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      Les |Principal

      I can help you with this issue. I have more than 40 years of experience in the *****st...

      4 Minutes Later
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      Gregory |Principal

      Hello. I am former FDA-drug safety, risk *****, and drug safety board. I'd be happy to disc...

      9 Minutes Later
    +20 Other Responses
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