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Search Results Judgments > Phrase:food safety and standards amendment act

Jun 18 1973

Weinberger v. Hynson, Wescott & Dunning, Inc.

  • Decided on : 18-Jun-1973

Court : US Supreme Court

... of any "new drug" unless a new drug application (NDA) filed with the Food and Drug Administration (FDA) was effective with respect to such drug. Under the Act, procedures were established for filing "new drug" applications not only for the safety of drugs but for their efficacy as well. Standards were provided under which, after notice and hearing, FDA could refuse to allow an ... Pharmaceutical Corp. v. Weinberger, post, p. 412 U. S. 655 , all here on certiorari, raise a series of questions under the 1962 amendments [ Footnote 1 ] to the Federal Food, Drug, and Cosmetic Act of 1938. 52 Stat. 1040. The 1938 Act, which established a system of pre-marketing clearance for drugs, prohibited the introduction into commerce of any "new drug" unless a new ... as amended in 1962, establishes a system of pre-marketing clearance for drugs and prohibits in 505(a) the introduction into commerce of any "new drug" unless a new drug application (NDA) filed with the Food and Drug Administration (FDA) was effective with respect to such drug. Under the Act, procedures were established for filing "new drug" applications not only for the safety ... Act permitted evaluation of a new drug solely on the basis of its safety. When the 1962 amendments became effective, Hynson submitted evidence of the efficacy of the drug, but the NAS-NRC panel reported that Hynson had not satisfied the requirements. Notice of an intention to withdraw approval of the NDA's covering the drug was given by the Commissioner of Food ...

May 06 2013

G. Sundarrajan Vs. Union of India & Others

  • Decided on : 06-May-2013

Court : Supreme Court of India

... safety functions envisaged under Sections 16, 17 and 23 of the Act. The AERB have powers to lay down safety standards and frame rules and regulations in regard to the regulatory and safety requirements envisaged under the Act and have to report to AEC. The Act underwent amendment vide amending Acts 59 and 29 in the years 1986 and 1987 respectively. However, the major amendment was of the year 1987, vide Amending Act ... of a licence. The Atomic Energy (Control of Irradiation of Food) Rules, 1990 (revised in 1996) seeks to regulate the irradiation of foods in the country. Provisions of the Act, statutory rules and regulations, various codes, safety standards etc. issued by the AERB buttressed by the technical assistance ... Act, constituted the Atomic Energy Regulatory Board (AERB) vide notification dated 15.11.1983 to carry out certain regulatory and safety functions envisaged under Sections 16, 17 and 23 of the Act. The AERB have powers to lay down safety standards and frame rules and regulations in regard to the regulatory and safety requirements envisaged under the Act and have to report to AEC. The Act underwent amendment vide amending Acts ... safety guides laid down by the AERB for maintaining high safety standards for setting up and for the functioning of nuclear plants in the country. AERB Safety Codes 26. AERB, as already indicated, was constituted by the Central Government in exercise of powers conferred under Section 27 of the Act to carry out certain regulatory and safety ...

May 06 2013

G.SUNDARRAJAN Vs. UNION OF INDIA & ORS.

  • Decided on : 06-May-2013

Court : Supreme Court of India

... safety functions envisaged under Sections 16, 17 and 23 of the Act. The AERB have powers to lay down safety standards and frame rules and regulations in regard to the regulatory and safety requirements envisaged under the Act and have to report to AEC. The Act underwent amendment vide amending Acts 59 and 29 in the years 1986 and 1987 respectively. However, the major amendment was of the year 1987, vide Amending Act ... of a licence. The Atomic Energy (Control of Irradiation of Food) Rules, 1990 (revised in 1996) seeks to regulate the irradiation of foods in the country. Provisions of the Act, statutory rules and regulations, various codes, safety standards etc. issued by the AERB buttressed by the technical assistance ... Act, constituted the Atomic Energy Regulatory Board (AERB) vide notification dated 15.11.1983 to carry out certain regulatory and safety functions envisaged under Sections 16, 17 and 23 of the Act. The AERB have powers to lay down safety standards and frame rules and regulations in regard to the regulatory and safety requirements envisaged under the Act and have to report to AEC. The Act underwent amendment vide amending Acts ... safety guides laid down by the AERB for maintaining high safety standards for setting up and for the functioning of nuclear plants in the country. AERB Safety Codes 26. AERB, as already indicated, was constituted by the Central Government in exercise of powers conferred under Section 27 of the Act to carry out certain regulatory and safety ...

Apr 23 1996

Medtronic, Inc. v. Lohr

  • Decided on : 23-Apr-1996

Court : US Supreme Court

... APPEALS FOR THE ELEVENTH CIRCUIT No. 95-754. Argued April 23, 1996-Decided June 26,1996* Enacted "to provide for the safety and effectiveness of medical devices intended for human use," the Medical Device Amendments of 1976 (MDA or Act) classifies such devices based on the risk that they pose to the public. Class III devices pose the greatest risk and ... and the state tort suit are identical. To distinguish between them for preemption purposes would grant greater power (to set state standards "different from, or in addition to," federal standards) to a single state jury than to state officials acting through state administrative or legislative lawmaking processes. Where Congress likely did not focus specifically upon the matter, see ante, at ... It is so ordered. JUSTICE BREYER, concurring in part and concurring in the judgment. This action raises two questions. First, do the Medical Device Amendments of 1976 (MDA) to the Federal Food, Drug, and Cosmetic Act ever pre-empt a state-law tort action? Second, if so, does the MDA pre-empt the particular state-law tort claims at issue here ... "substantially equivalent" devices, has never been formally reviewed under the MDA for safety or efficacy. The FDA stressed this basic conclusion in its letter to Medtronic finding the 4011 lead "substantially equivalent" to devices already on the market. That letter only required Medtronic to comply with "general standards"-the lowest level of protection "applicable to all medical devices," and including ...

Feb 20 2008

Riegel v. Medtronic, Inc.

  • Decided on : 20-Feb-2008

Court : US Supreme Court

... the pre-emption clause enacted in the Medical Device Amendments of 1976, 21 U. S. C. 360k, bars common-law claims challenging the safety and effectiveness of a medical device given premarket approval by the Food and Drug Administration (FDA). I A The Federal Food, Drug, and Cosmetic Act (FDCA), 52 Stat. 1040, as amended, 21 U. S. C. 301 et seq. , has long ... As Justice Breyer explained in Lohr , it is implausible that the MDA was meant to grant greater power (to set state standards different from, or in addition to federal standards) to a single state jury than to state officials acting through state administrative or legislative lawmaking processes. 518 U. S., at 504. That perverse distinction is not required or even suggested ... FDA evaluates safety and effectiveness under the conditions of use set forth on the label, 360c(a)(2)(B), and must determine that the proposed labeling is neither false nor misleading, 360e(d)(1)(A). After completing its review, the FDA may grant or deny premarket approval. 360e(d). It may also condition approval on adherence to performance standards, 21 ... . ___ (2008). The question presented in that case is: Whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration (FDA) pursuant to FDAs comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, 21 U. S. C. 301 et seq ., preempt state law product liability claims premised on the theory that different labeling ...

Mar 04 2009

Wyeth v. Levine

  • Decided on : 04-Mar-2009

Court : US Supreme Court

... Safety Vehicle Act of 1966, which directs the Secretary of the Department of Transportation (DOT) to establish by order motor vehicle safety standards, 15 U. S. C. 1392(a) (1988 ed.), which are defined as minimum standard[s] for motor vehicle performance, or motor vehicle equipment performance, 1391(2). Acting pursuant to that statutory mandate, the Secretary of Transportation promulgated Federal Motor Vehicle Safety Standard ... pre-emption in the FDCA. See Drug Amendments of 1962, 202, 76 Stat. 793 (Nothing in the amendments made by this Act to the Federal Food, Drug, and Cosmetic Act shall be construed as invalidating any provision of State law unless there is a direct and positive conflict between such amendments and such provision of State law). ... Safety Act of 1966 (Safety Act), 80 Stat. 718, 15 U. S. C. 1381 et seq. (1988 ed.), the Department of Transportation (DOT) had promulgated a Federal Motor Vehicle Safety Standard that required auto manufacturers to equip some but not all of their 1987 vehicles with passive restraints. 529 U. S., at 864865. The case required this Court to decide whether the Safety Act ... vehicle equipment[,] any safety standard applicable to the same aspect of performance of such vehicle or item of equipment which is not identical to the Federal standard. 15 U. S. C. 1392(d) (1988 ed.). The Safety Act also included a saving clause, which stated: Compliance with any Federal motor vehicle safety standard issued under this subchapter ...

Mar 24 2011

M/s. L and T Komatsu Ltd., Bangalore, rep. by its Assistant General Ma ...

  • Decided on : 24-Mar-2011

Court : Karnataka

... food, health, rest and other welfare measures. 74. By Act 94/1976, the provisions of the Factories Act came to be amended. The main object of the Factories Act, 1948 was to ensure adequate safety measures and to promote health and welfare of the workers employed in factories. The Government therefore has initiated various measures from time to time to ensure that adequate standards of safety ... standards of safety, health and welfare are achieved at all work places. In particular in the context of the need to secure maximum production and productivity, an appropriate work culture conducive to safety, health and happiness of workers has to be evolved in the factories. To achieve these objectives more effectively it became necessary to amend the Factories Act. The amendments ... standards of safety, health and welfare and achieved at all work places. In particular, in the context of the need to secure maximum production and productivity an appropriate work culture conducive to the safety, health and happiness of workers has to be evolved in the factories. To achieve these objects more effectively, this enactment has been made. In fact, by amendments ... judgment that: The Factories Act has been enacted to regulate labour in factories. The main object of that is to ensure adequate safety measures and to promote the health and welfare of the workers employed in factories initiating various measures from time to time to ensure that adequate standards of safety, health and welfare and achieved ...

Jun 11 1993

Church of Lukumi Babalu Aye, Inc. v. Hialeah

  • Decided on : 11-Jun-1993

Court : US Supreme Court

... Church, 393 U. S. 440 , 449 (1969). In this case we need not define with precision the standard used to evaluate whether a prohibition is of general application, for these ordinances fall well below the minimum standard necessary to protect First Amendment rights. Respondent claims that Ordinances 87-40, 87-52, and 87-71 advance two interests: protecting the ... INC. v. HIALEAH contained an exemption for slaughtering by "licensed establishment[s]" of animals "specifically raised for food purposes." Declaring, moreover, that the city council "has determined that the sacrificing of animals within the city limits is contrary to the public health, safety, welfare and morals of the community," the city council adopted Ordinance 87-71. That ordinance defined " ... sought a declaratory judgment and injunctive and monetary relief. The District Court granted summary judgment to the individual defendants, finding that they had absolute immunity for their legislative acts and that the ordinances and resolutions adopted by the council did not constitute an official policy of harassment, as alleged by petitioners. 688 F. Supp. 1522 (SD Fla. ... to fail the test of general applicability, and as the Court "need not define with precision the standard used to evaluate whether a prohibition is of general application, for these ordinances fall well below the minimum standard necessary to protect First Amendment rights," ante, at 543, it need not discuss the rules that apply to prohibitions found to be ...

Jun 06 1994

Farmer v. Brennan

  • Decided on : 06-Jun-1994

Court : US Supreme Court

... safety may be found free from liability if they responded reasonably to the risk, even if the harm ultimately was not averted. A prison official's duty under the Eighth Amendment is to ensure "'reasonable safety,'" Helling, supra, at 33; see also Washington v. Har- 845 per, 494 U. S., at 225; Hudson v. Palmer, 468 U. S., at 526527, a standard ... Amendment for acting with "deliberate indifference" to inmate health or safety only if he knows that inmates face a substantial risk of serious harm and disregards that risk by failing to take reasonable measures to abate it. Pp.832-851. (a) Prison officials have a duty under the Eighth Amendment to provide humane conditions of confinement. They must ensure that inmates receive adequate food ... safety of which he was ignorant but should have known-fails under even "a straightforward application of Estelle." Helling, supra, at 42 (THOMAS, J., dissenting). In adopting the "deliberate indifference" standard for challenges to prison conditions, Estelle held that mere "inadverten[ce]" or "negligen[ce]" does not violate the Eighth Amendment ...

Jun 18 1979

United States v. Rutherford

  • Decided on : 18-Jun-1979

Court : US Supreme Court

... of the 1938 Food, Drug, and Cosmetic Act, which first established procedures for review of drug safety, or of the 1962 Amendments, which added the current safety and effectiveness standards in 201(p)(1), [ Footnote 8 ] suggests that Congress intended protection only for persons suffering from curable diseases. To the contrary, in deliberations preceding the 1938 Act, Congress expressed ... no demonstrable curative properties, the consequences can be irreversible. [ Footnote 13 ] For this reason, even before the 1962 Amendments incorporated an efficacy standard into new drug application procedures, the FDA considered effectiveness when reviewing the safety of drugs used to treat terminal illness. See nn. 8 9 supra. The FDA's practice also reflects the ... Act, 52 Stat. 1041, as amended, 21 U.S.C. 321 (p)(1). I Section 505 of the Federal Food, Drug, and Cosmetic Act, 52 Stat. 1052, as amended, 21 U.S.C. 355, prohibits interstate distribution of any "new drug" unless the Secretary of Health, Education, and Welfare approves an application supported by substantial evidence of the drug's safety ... Act that no implicit exemption for drugs used by the terminally ill is necessary to attain congressional objectives or to avert an unreasonable reading of the terms "safe" and "effective" in 201(p)(1). A Nothing in the history of the 1938 Food, Drug, and Cosmetic Act, which first established procedures for review of drug safety, or of the 1962 Amendments, which added the current safety ...

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