A statute of limitations, (known in civil law systems as a prescriptive period), is a law passed by a legislative body to set the maximum time after an event within which legal proceedings may be initiated.[1][2] In most jurisdictions, such periods exist for both criminal law and civil law such as contract law and property law, though often under different names and with varying details.
When the time which is specified in a statute of limitations runs out, a claim might no longer be filed or, if it is filed, it may be subject to dismissal if the defense against that claim is raised that the claim is time-barred as having been filed after the statutory limitations period.[3]
When a statute of limitations expires in a criminal case, the courts no longer have jurisdiction. Most common crimes that have statutes of limitations are distinguished from particularly serious crimes because the latter claims may be brought at any time.
In civil law systems, such provisions are typically part of their civil and criminal codes. The cause of action dictates the statute of limitations, which can be reduced or extended in order to ensure a full and fair trial.[4] The intention of these laws is to facilitate resolution within a "reasonable" period of time.[5] What amount of time is considered "reasonable" varies from country to country.[6] In the United States, it may vary from jurisdiction to jurisdiction and state to state. Internationally, the statute of limitations may vary from one civil or criminal action to another. Some countries have no statute of limitations whatsoever.
Analysis of a statute of limitations also requires the examination of any associated statute of repose, tolling provisions, and exclusions.
https://en.wikipedia.org/wiki/Statute_of_limitations
Limitations and exceptions to copyright are provisions, in local copyright law or the Berne Convention, which allow for copyrighted works to be used without a license from the copyright owner.
Limitations and exceptions to copyright relate to a number of important considerations such as market failure, freedom of speech,[1] education and equality of access (such as by the visually impaired). Some view limitations and exceptions as "user rights"—seeing user rights as providing an essential balance to the rights of the copyright owners. There is no consensus among copyright experts as to whether user rights are rights or simply limitations on copyright. The concept of user rights has been recognised by courts, including the Canadian Supreme Court,[2] which classed "fair dealing" as such a user right. These kinds of disagreements in philosophy are quite common in the philosophy of copyright, where debates about jurisprudential reasoning tend to act as proxies for more substantial disagreements about good policy.
https://en.wikipedia.org/wiki/Limitations_and_exceptions_to_copyright
https://en.wikipedia.org/wiki/Pirate_Party
https://en.wikipedia.org/wiki/Old_Norse
https://en.wikipedia.org/wiki/Freedom_of_speech#Limitations
https://en.wikipedia.org/wiki/Censorship
https://en.wikipedia.org/wiki/Philosophy_of_copyright
https://en.wikipedia.org/wiki/Intellectual_property
https://en.wikipedia.org/wiki/Patent
https://en.wikipedia.org/wiki/Gang
https://en.wikipedia.org/wiki/Censorship
The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) or Biologics License Application (BLA) was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities. In order to continue collecting such fees, the FDA is required to meet certain performance benchmarks, primarily related to the speed of certain activities within the NDA review process.
https://en.wikipedia.org/wiki/Prescription_Drug_User_Fee_Act
A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows:
The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for a license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA. This includes:
- Applicant information
- Product/manufacturing information
- Pre-clinical studies
- Clinical studies
- Labeling[1]
Some biological products are regulated by the Center for Drug Evaluation and Research (CDER) while others are regulated by Center for Biologics Evaluation and Research (CBER).[2]
A BLA is submitted after an investigational new drug has been approved. If the Form 356h is missing information, the FDA will reply within 74 days.[3] A BLA asserts that the product is "safe, pure, and potent", the manufacturing facilities are inspectable, and each package of the product bears the license number.
After approval, annual reports, reports on adverse events, manufacturing changes, and labeling changes must be submitted.
See also
References
- Group, The FDA. "The Biologics License Application (BLA) Process Explained". www.thefdagroup.com.
- Food and Drug Administration
- Intellectual property law
- Pharmaceutical industry
- American medical research
- Drug safety
- Experimental drugs
- United States federal health legislation
- Biotechnology products
https://en.wikipedia.org/wiki/Biologics_license_application
A statute of repose (sometimes called a nonclaim statute), like a statute of limitations, is a statute that cuts off certain legal rights if they are not acted on by a specified deadline.[1]
Statutes of repose exist in a number of contexts. Some jurisdictions have passed statutes of repose in the context of products liability law, or for probate court proceedings.
https://en.wikipedia.org/wiki/Statute_of_repose
Forum non conveniens (Latin for "an inconvenient forum"[1][2][3]) (FNC) is a mostly common law legal doctrine through which a court acknowledges that another forum or court where the case might have been brought is a more appropriate venue for a legal case, and transfers the case to such a forum. A change of venue might be ordered, for example, to transfer a case to a jurisdiction within which an accident or incident underlying the litigation occurred and where all the witnesses reside.[4]
https://en.wikipedia.org/wiki/Forum_non_conveniens
In law, fraud is intentional deception to secure unfair or unlawful gain, or to deprive a victim of a legal right. Fraud can violate civil law (e.g., a fraud victim may sue the fraud perpetrator to avoid the fraud or recover monetary compensation) or criminal law (e.g., a fraud perpetrator may be prosecuted and imprisoned by governmental authorities), or it may cause no loss of money, property, or legal right but still be an element of another civil or criminal wrong.[1] The purpose of fraud may be monetary gain or other benefits, for example by obtaining a passport, travel document, or driver's license, or mortgage fraud, where the perpetrator may attempt to qualify for a mortgage by way of false statements.[2]
Internal fraud, also known as "insider fraud", is fraud committed or attempted by someone within an organisation such as an employee.[3]
A hoax is a distinct concept that involves deliberate deception without the intention of gain or of materially damaging or depriving a victim.
https://en.wikipedia.org/wiki/Fraud
The Hague Conference on Private International Law (HCCH) is an intergovernmental organisation in the area of private international law (also known as conflict of laws), that administers several international conventions, protocols and soft law instruments.
The Hague Conference was first convened by Tobias Asser in 1893 in The Hague. In 1911, Asser received the Nobel Prize for Peace for his work in the field of private international law, and in particular for his achievements with respect to the HCCH. After World War II, the Hague Conference was established as an international organisation.
https://en.wikipedia.org/wiki/Hague_Conference_on_Private_International_Law
Conflict of laws (also called private international law) is the set of rules or laws a jurisdiction applies to a case, transaction, or other occurrence that has connections to more than one jurisdiction.[1] This body of law deals with three broad topics: jurisdiction, rules regarding when it is appropriate for a court to hear such a case; foreign judgments, dealing with the rules by which a court in one jurisdiction mandates compliance with a ruling of a court in another jurisdiction; and choice of law, which addresses the question of which substantive laws will be applied in such a case.[2] These issues can arise in any private-law context,[2] but they are especially prevalent in contract law[3][4][5][6][7][8][9][10] and tort law.[11]
https://en.wikipedia.org/wiki/Conflict_of_laws
https://en.wikipedia.org/wiki/foundation
https://en.wikipedia.org/wiki/clemency
https://en.wikipedia.org/wiki/execution_euthanasia_death_no_Delay
https://en.wikipedia.org/wiki/all-or-nothing
https://en.wikipedia.org/wiki/black-and-white-thinking
https://en.wikipedia.org/wiki/grey
Lex causae (Latin for "law of the cause"), in conflict of laws, is the law chosen by the forum court from the relevant legal systems when it judges an international or interjurisdictional case. It refers to the usage of particular local laws as the basis or "cause" for the ruling, which would itself become part of referenced legal canon.
Conflict of laws regulates all lawsuits involving foreign law if the outcome of a legal action would differ by the laws applied. Once the forum court has ruled that it has jurisdiction to hear the case, it must then decide which possible law is to be applied.
https://en.wikipedia.org/wiki/Lex_loci#Lex_causae
https://en.wikipedia.org/wiki/Incidental_question
In the conflict of laws, lex loci actus or lex actus[2] is the law of the place where the act occurred that gave rise to the legal claim. This is often confused with lex loci delicti commissi which is where the tort is committed. While typically they both point to the same location, in the case of product liability, for example, the lex loci actus would be the place of manufacturing, while the lex loci delicti commissi would be the place of injury.
https://en.wikipedia.org/wiki/Lex_loci#Lex_loci_actus
The lex loci arbitri is the Latin term for "law of the place where arbitration is to take place" in the conflict of laws. Conflict is the branch of public law regulating all lawsuits involving a "foreign" law element where a difference in result will occur depending on which laws are applied.
https://en.wikipedia.org/wiki/Lex_loci#Lex_loci_actus
https://en.wikipedia.org/wiki/Proper_law
https://en.wikipedia.org/wiki/Deportation
https://en.wikipedia.org/wiki/death
https://en.wikipedia.org/wiki/return
https://en.wikipedia.org/wiki/kill-or-release
Investment is traditionally defined as the "commitment of resources to achieve later benefits". If an investment involves money, then it can be defined as a "commitment of money to receive more money later". From a broader viewpoint, an investment can be defined as "to tailor the pattern of expenditure and receipt of resources to optimise the desirable patterns of these flows". When expenditure and receipts are defined in terms of money, then the net monetary receipt in a time period is termed as cash flow, while money received in a series of several time periods is termed as cash flow stream. Investment science is the application of scientific tools (usually mathematical) for investments.[1]
In finance, the purpose of investing is to generate a return from the invested asset. The return may consist of a gain (profit) or a loss realized from the sale of a property or an investment, unrealized capital appreciation (or depreciation), or investment income such as dividends, interest, or rental income, or a combination of capital gain and income. The return may also include currency gains or losses due to changes in the foreign currency exchange rates.
Investors generally expect higher returns from riskier investments. When a low-risk investment is made, the return is also generally low. Similarly, high risk comes with a chance of high losses.
Investors, particularly novices, are often advised to diversify their portfolio. Diversification has the statistical effect of reducing overall risk.
https://en.wikipedia.org/wiki/Investment
https://en.wikipedia.org/wiki/IP
https://en.wikipedia.org/wiki/body
https://en.wikipedia.org/wiki/tools
https://en.wikipedia.org/wiki/work
https://en.wikipedia.org/wiki/ledger
https://en.wikipedia.org/wiki/assigned-sequence
https://en.wikipedia.org/wiki/training-apprentice
https://en.wikipedia.org/wiki/term-account
A ledger[1] is a book or collection of accounts in which account transactions are recorded. Each account has an opening or carry-forward balance, and would record each transaction as either a debit or credit in separate columns, and the ending or closing balance.
https://en.wikipedia.org/wiki/Ledger
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