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NOTICES: Advisory committees; tentative schedule (2007),
Published: 2006-12-29
The Food and Drug Administration (FDA) is announcing a
tentative schedule of forthcoming meetings of its public advisory
committees for 2007. During 1991, at the request of the Commissioner of
Food and Drugs (the Commissioner), the Institute of Medicine (the IOM)
conducted a study of the use of FDA's advisory committees. In its final
report, one
PROPOSED RULES: Internal analgesic, antipyretic, and antirheumatic products (OTC); tentative final monograph; required warnings and other labeling,
Published: 2006-12-26
The Food and Drug Administration (FDA) is proposing to amend
its overthecounter (OTC) labeling regulations and the tentative final
monograph (TFM) for OTC internal analgesic, antipyretic, and
antirheumatic (IAAA) drug products to include new warnings and other
labeling requirements advising consumers about potential risks and when
to consult a
NOTICES: Premarket notification exemptions; Class II devices—; Cranial orthosis type devices,
Published: 2006-12-26
The Food and Drug Administration (FDA) is publishing an order
denying a petition requesting exemption for cranial orthosis type
devices from the premarket notification requirements for certain class
II devices. A cranial orthosis device is a device intended to apply
pressure to prominent regions of an infant's cranium in order to
improve cranial
NOTICES: Medical Devices Advisory Committee,
Published: 2006-12-26
The Food and Drug Administration (FDA) is announcing an amendment
to the notice of the meeting of the Neurological Devices Panel of the
Medical Devices Advisory Committee. This meeting was originally
announced in the Federal Register of December 6, 2006 (71 FR page
70780). The amendment is being made to reflect a change in the Agenda
portion
NOTICES: Reproductive Health Drugs Advisory Committee,
Published: 2006-12-22
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Name of Committee: Advisory Committee for Reproductive Health Drugs.
General Function of the Committee: To provide advice and
recommendations to the agency on FDA's regulatory
NOTICES: Additional safeguards for children in clinical investigations; process for handling referrals to FDA,
Published: 2006-12-22
The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``Guidance for Clinical
Investigators, Institutional Review Boards, and Sponsors; Process for
Handling Referrals to FDA Under 21 CFR 50.54: Additional Safeguards for
Children in Clinical Investigations.'' This guidance is intended to
assist clinical
RULES: Gentamicin,
Published: 2006-12-22
The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of an abbreviated new animal drug
application (ANADA) filed by Sparhawk Laboratories, Inc. The ANADA
provides for use of a gentamicin sulfate injectable solution in piglets
for treatment of porcine colibacillosis.
RULES: Disqualification of a clinical investigator; technical amendment,
Published: 2006-12-22
The Food and Drug Administration (FDA) is amending a medical
device regulation to include references to the Center for Biologics
Evaluation and Research (CBER) and the Center for Drug Evaluation and
Research (CDER). This regulation pertains to the disqualification of a
clinical investigator. Currently, only a reference to the Center for
Devices
RULES: Food labeling—; Uniform compliance date,
Published: 2006-12-21
The Food and Drug Administration (FDA) is establishing January
1, 2010, as the uniform compliance date for food labeling regulations
that are issued between January 1, 2007, and December 31, 2008. FDA
periodically announces uniform compliance dates for new food labeling
requirements to minimize the economic impact of label changes. On March
14,
NOTICES: Post-approval studies imposed by premarket approval application order; handling procedures,
Published: 2006-12-21
The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Procedures for Handling Post
Approval Studies Imposed by PMA Order.'' The guidance provides a
standard format and content for submitting postapproval studies. The
guidance is issued to help ensure that sponsors provide adequate
information about the
NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-20
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-20
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
NOTICES: Marketed unapproved drugs application process; workshop,
Published: 2006-12-20
The Food and Drug Administration (FDA) is announcing a change
of location and time for the upcoming public workshop on marketed
unapproved drugs. Registration for the public workshop is closed. A new
address and time are given for those persons who have previously
registered with FDA.
RULES: Gloves; patient examination and surgeon's gloves; test procedures and acceptance criteria,
Published: 2006-12-19
The Food and Drug Administration (FDA) is issuing a final rule
to improve the barrier quality of medical gloves marketed in the United
States. The rule will accomplish this by reducing the current
acceptable quality levels (AQLs) for leaks and visual defects observed
during FDA testing of medical gloves. By reducing the AQLs for medical
gloves,
NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-18
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-18
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-15
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-15
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
NOTICES: Drug products withdrawn from sale for reasons other than safety or effectiveness—; Quinine-containing drug products; enforcement action dates,
Published: 2006-12-15
The Food and Drug Administration (FDA) is announcing its
intention to take enforcement action against unapproved drug products
containing quinine (including quinine sulfate and any other salt of
quinine) and persons who cause the manufacture of such products or
their shipment in interstate commerce. Drug products containing
quinine, quinine
NOTICES: Convention on Psychotropic Substances—; World Health Organization scheduling recommendations for dronabinol and its stereoisomers, and oripavine,
Published: 2006-12-15
The Food and Drug Administration (FDA) is providing interested
persons with the opportunity to submit written comments concerning
recommendations by the World Health Organization (WHO) to impose
international manufacturing and distributing restrictions, under
international treaties, on certain drug substances. The comments
received in response to
PROPOSED RULES: Investigational drugs; sale,
Published: 2006-12-14
The Food and Drug Administration (FDA) is proposing to amend
its investigational new drug application (IND) regulation concerning
charging patients for investigational new drugs. FDA is proposing to
revise the current charging regulation to clarify the circumstances in
which charging for an investigational drug in a clinical trial is
appropriate,
PROPOSED RULES: Investigational drugs; treatment use; expanded access,
Published: 2006-12-14
The Food and Drug Administration (FDA) is proposing to amend
its regulations on access to investigational new drugs for the
treatment of patients. The proposed rule would clarify existing
regulations and add new types of expanded access for treatment use.
Under the proposal, expanded access to investigational drugs for
treatment use would be
RULES: Approved and abbreviated new drug applications; supplements and other changes,
Published: 2006-12-13
The Food and Drug Administration (FDA) is amending its
regulations on supplements and other changes to approved new animal
drug applications (NADAs) or abbreviated new animal drug applications
(ANADAs) to implement the manufacturing changes provision of the Food
and Drug Administration Modernization Act of 1997 (the Modernization
Act). The final
RULES: Food labeling—; Dietary supplements; nutrition labeling on ‘per day’ basis,
Published: 2006-12-13
The Food and Drug Administration (FDA) is amending its
nutrition labeling regulations for dietary supplements to provide that
the quantitative amount and the percent of Daily Value of a dietary
ingredient may be voluntarily presented on a ``per day'' basis in
addition to the required ``per serving'' basis when a recommendation is
made on the
NOTICES: Agency information collection activities; proposals, submissions, and approvals,
Published: 2006-12-13
The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.