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Useful Articles - Even Courts Rely on Mapquest
On January 25, 2007 the United States Court of Appeals for the Seventh Circuit granted a habeas corpus petition relyin
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
g, in part, upon calculations performed by popular driving direction website Mapquest to determine that the petitioner’s tria
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
l counsel had not properly explored petitioner’s alibi before or during his trial on charges of murder and attempted murder.
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
u>Raygoza v. Hulick, ___ F.3d ___, 2007 WL 184635 (7th Cir. 2007). The Court used Mapquest to determine the distance and
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
travel time between the crime scene and a party petitioner had attended near the time of the crime.
It’s not the first time
It’s not the first time
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
that Mapquest has been cited as authority in a case. A number of state and federal courts have relied upon Mapquest to determ
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
ne the distance or travel time between two points. Mapquest has been cited in dozens of reported decisions, including rulings
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
on:
- motions to change venue in civil cases, where the convenience of the forum to parties and potential witnesses w
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
as an issue. Smith v. State Farm Mut. Auto. Ins. Co., 169 Md. App. 286, 292, 900 A.2d 301, 305 (2006); Hoskin v. Un
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
Pacific Railroad Co., 365 Ill. App.3d 1021, 1025, 851 N.E.2d 646, 650 (2006)
motions to transfer a federal criminal
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
case to another district. United States v. Anderson, 2000 WL 34237505, *7 (W.D. Wis. 2000); United States v. Fergu
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
son, 432 F.Supp.2d 559, 563 n. 5 (E.D. Va. 2006)
a motion to dismiss, in which the court took judicial notice of the
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
driving distance calculated by Mapquest. Untracht v. Fikri, 454 F.Supp.2d 289, 302 (W.D. Pa. 2006) (citing Gordon v
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
. Lewistown, 272 F.Supp.2d 393, 429 n. 34 (M.D. Pa. 2003))
However, at least one court has held that courts should
However, at least one court has held that courts should
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
not take judicial notice of Mapquest results because the website is not sufficiently accurate. Commonwealth v. Brown,
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
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
39 A.2d 433, 436-37 (Pa. Super. 2003) ("An internet site determining distances does not have the same inherent accuracy as do
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
professionally accepted medical dictionaries, or encyclopedias, or other matters of common knowledge within the community. T
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
he, we hold that the trial court abused its discretion in taking judicial notice of a MapQuest distance determination . . . .
.
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
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
)
Though trial counsel may not be able to count on Mapquest to produce admissible evidence where a timely objection is raise
Though trial counsel may not be able to count on Mapquest to produce admissible evidence where a timely objection is raise
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
d, unchallenged Mapquest results are routinely considered by courts in determining distance or travel time between two points
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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