Useful Articles - Writing and Speaking

* Will this be Published by Debit or Deposit?

A new writer asks the question;

I have submitted a book for publishing and they said th

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

at I need to pay them for a critique. Is this a gimmik. Please help.

If they are a reputable publishing company you shouldn't have to pay any

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

hing, especially when they haven't even accepted your book. I would be very wary of them. How badly do you want to see your work in print? The

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

re are plenty of unscrupulous people who are always ready and eager to take your money. They are in the business of selling empty promises and th

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

y’re very successful. Be careful out there.

* Agents who charge reading fees.

Legitimate agents earn their money by selling marketable

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

material to publishers. They are paid by commission on everything they sell and don’t waste time with material that won’t. If they charge readin

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

g fees, they don’t care whether the work is saleable or not. Your MS is tossed aside and your check is deposited in their account. They’ve alrea

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

y been paid – by you. You’re no closer to publication then you were before you paid them to read it.

Pay a reader-editor if you want to, t

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ey can be very helpful; but do it before submitting the work to a publisher. Be careful though. Remember, anyone can claim anything.

* Agent

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

s who scout for customers.

Reputable agents usually have more work than they can handle. They don’t have time nor the desire to search pers

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

nal websites for unknown authors. If an agent solicits your work, be suspicious. If the ads guarantee to get you published, run!

Amateur author

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

are often so excited to be contacted by an agent that they are willing to grab at any offer. Remember, if something seems too good to be true, i

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

t usually is.

* Agents who refer you to a specific independent editor or ‘book doctor.’

If you’re told your book is almost good enough

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

o publish but needs work, and then refer you to a specific editor, run! It's most likely a scam the two of them are working. Reputable

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

Pubishers and Agents will offer tips and suggestions for editing, but they won’t tell you to hire someone else to do the work. A real age

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

nt or publisher will expect you to be good enough to finish it yourself. They look forward to another book down the road, and want an author the

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

can depend on to make money for them. You should view specific referrals as suspect.

* A publisher who asks for an ‘investment’ to defray cos

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

s.

If a reputable publishing house doesn’t believe your manuscript is worth the financial risk, it will simply reject it; it won’t ask you to

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

pay for publication.

* The golden rule of publishing is simple:

Money flows from the market to the writer, not the other way around.

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

f your money is flowing in the wrong direction, someone is taking advantage of you.

For more information on scams, see http://www.sfwa.org/beware

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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