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Searching Content indexed under Food and Drugs Law by Carolyn Alenci ordered by Published Date Descending.
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1
BYOD And eCOA: A Match Made In Heaven?
Patient-focused drug development and the selection and development of Clinical Outcome Assessments (COA) continue to be a focus for the U.S. Food and Drug Administration (FDA).
United States
23 Sep 2019
2
DEA Announcement On Improving Access To Marijuana Research
On August 26, 2019, the Drug Enforcement Agency (DEA) issued a press release announcing "it is moving forward to facilitate and expand scientific and medical research for marijuana in the United States."
United States
4 Sep 2019
3
OTC Personal Products Manufacturer Cited By FDA For Various Regulatory Violations
On August 20, 2019, the U.S. Food and Drug Administration announced that it had sent and posted a warning letter to an over-the-counter drug manufacturer citing "significant"
United States
29 Aug 2019
4
FDA Releases Guidance On REMS Modifications And Revisions
On July 9, 2019, the U.S. Food and Drug Administration (FDA) released a final guidance on changes to approved Risk Evaluation and Mitigation Strategies (REMS).
United States
23 Aug 2019
5
FTC Issues Report On Its Authority Under Section 5 Of The FTC Act To Challenge Pharmaceutical Drug Price Increases
On June 24, 2019, in response to a directive from Congress, the Federal Trade Commission (FTC) issued a report to the House and Senate Appropriations Committees on the use of the FTC's
United States
30 Jul 2019
6
FDA Comments On The Public Hearing On Products Containing Cannabis And Cannabis-Derived Compounds And Extends Comment Period
At the U.S. Food and Drug Administration's (FDA) public hearing on May 31, 2019 (read more about the hearing), over 100 people presented to a panel of FDA stakeholders and to over 500 attendees.
United States
25 Jul 2019
7
The 2018 Farm Bill Preserves FDA Right To Regulate Cannabis Products
Last year was a record year for cannabis. Canada passed the Cannabis Act, making adult-use cannabis legal there. The FDA approved a cannabidiol-based medicine, Epidiolex.
United States
11 Feb 2019
8
FDA Issues Final Guidance On Data Integrity And Compliance With Drug CGMP
Data integrity means complete, consistent and accurate recording of data. This requires an original or true copy of contemporaneously recorded data that is attributable to a specific individual and is legible and accurate.
United States
18 Jan 2019
9
CDER's New MAPP On Risk-Based Site Selection Model For Routine Inspections
The list is developed from inputting sites from CDER's Catalog of Manufacturing Sites into the SSM
United States
15 Nov 2018
10
FDA Rolls Out Pilot Of New Quality In 510(k) "Quik" Review Program
On September 6, 2018, the FDA launched an alternate to the Traditional 510(k) for submitting a Premarket Notification (510(k)).
United States
23 Oct 2018
11
FDA Unveils New Quality in 510(k) "Quik" Review Program Pilot
According to the FDA, one of its purposes is to evaluate whether use of the FDA's free eSubmitter software will produce well-organized submissions that can be reviewed more efficiently.
United States
23 Oct 2018
12
Case Study: Jazz Pharmaceuticals v. Amneal Pharmaceuticals
On July 13, 2018, the Federal Circuit decided Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, an appeal of six inter partes review decisions by the PTAB's finding that certain claims of seven patents ...
United States
18 Oct 2018
13
FDA Proposes To Amend Product Jurisdiction Regulations Without Any Significant Substantive Changes
This scheme, called the FDA's product jurisdiction, has remained largely unchanged since 1991.
United States
13 Jun 2018
14
FDA Issues Guidance On Self-Identification Of Generic Drug Facilities
The U.S. Food and Drug Administration (FDA) has published a guidance entitled "Self-Identification of Generic Drug Facilities, Sites, and Organizations."
United States
12 Oct 2016
15
FDA Issues Draft Guidance On Data Integrity And Compliance With CGMP
The U.S. Food and Drug Administration (FDA) has recently published the draft guidance, Data Integrity and Compliance with CGMP, which comes after years of increased data integrity issues worldwide, including issues with oversight, or control, of paper records and inadequacies of audit trails.
United States
5 May 2016
16
FDA Publishes Draft Guidance On Abuse-Deterrence Testing Of Generic Solid Oral Opioid Drug Products
FDA recommends in vitro studies for its suggested tier-based testing.
United States
25 Apr 2016
17
FDA Proposed Rule On Fixed-Combination And Co-Packaged Drugs
The U.S. Food and Drug Administration (FDA) published its proposed rule on fixed-combination and co-packaged drugs, which relates to both prescription and over-the-counter (OTC) drug products and to combinations of active ingredients under consideration for inclusion in an OTC monograph.
United States
17 Mar 2016
18
FDA Publishes Revised Guidance On Product Tracing Requirements For Dispensers
On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system by November 27, 2023, which will identify and trace certain prescription drugs as they are distributed in the United States."
United States
5 Nov 2015
19
FDA Opens Plan To Let Generic Drug Manufacturers Update Labels To Debate
In response to the U.S. Supreme Court's holding in Pliva v. Mensing that federal laws and regulations preempted state failure-to-warn claims, the U.S. FDA in 2013 proposed to allow generic drug manufacturers to update their warning labels unilaterally.
United States
26 Feb 2015
20
FDA Issues Additional Guidances On Implementation Of Drug Supply Chain Security Act
The U.S. Food and Drug Administration continues to publish draft guidances implementing the Drug Supply Chain Security Act.
United States
25 Feb 2015
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