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The Department of Labor (DOL) recently published the regulations for its Program Electronic Review Management (PERM) program after two years. The regu

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

lations will take effect on March 28, 2005.

February 16, 2005- The Department of Labor (DOL) recently published the regulations for its Program Elec

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

Examples of combination products may in

tronic Review Management (PERM) program after two years. The regulations will take effect on March 28, 2005.

The PERM regulations were first proposed

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

in May 2002. They were created to help streamline the permanent labor certification system, thus providing an answer to the current labor certificati

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

n backlog.

PERM is an electronic process that will be used for filing and processing labor certification applications for permanent employment-based

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

Combination pro

immigration.

One of the most significant changes to the process, under the new PERM regulations, would be the 45-to-60-days-period of processing for

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

electronically submitted applications through PERM. This means that DOL expects that files submitted will be decided within 45-60 days. Current situat

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

ion can take up to three (3) years of processing for labor certification applications. With the new PERM regulations, DOL contends that it will defini

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

ely speed up the process and provide for the means to get the present backlog done in no time.

Employers will be able to file a form electronically v

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

ia DOL's website when the rule takes effect in March. In addition, employers can also file labor certification applications by mailing them directly t

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

o the centralized processing center available. A listing may be viewed at htt

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

Following aspects would a

p://www.workforcesecurity.doleta.gov/foreign.

Some of the key features of the new PERM regulations include:

1. The employer must pay the sponsor

dd to the challenges in developing combination products:

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

d employee at least 100% of the prevailing wage for the position as determined by DOL.

2. The employer must provide the following requirements for re

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

cruitment: (a) advertisement to two Sunday newspaper editions; (b) undertake at least three additional means of recruitment as alternate forms of adve

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

rtising. For positions that require experience and an advanced degree, the employer is advised to substitute an advertisement in a national journal or

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

publication for one Sunday newspaper advertisement; and (c) place a 30-day job order with the DOL for the offered position.

3. The employer is requi

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

Professional from academic institutions, pharmaceutical industries, health care indust

ed to provide a conduct of recruitment for disqualifying candidates, layoffs, and audit, among others.

4. Employer with 10 or fewer employees must do

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

cument any family relationship between its employees and sponsored employee.

5. The DOL may question whether or not the position is open to US worker

.

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

s if the employee is "required" to pay legal fees.

6. Employers are allowed to withdraw and re-file Labor Certification Applications, while preservin

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

Companies that provide selfless information through particip

g the original filing date. However, applications found not to have "identical job opportunity" will be withdrawn and re-filed under a new filing date

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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Answers - ASE-PERM Regulations Published

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