Searching Content indexed under Food and Drugs Law by Frederick Ball ordered by Published Date Descending.
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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
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
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
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
DOJ Implements 2018 Granston Memo On False Claims Act
In early 2018, the U.S. Department of Justice announced a new policy encouraging prosecutors handling False Claims Act (FCA) ...
United States
10 Jan 2019
FDA Publishes Redraft Of 510(K) Third Party Review Program
Section 523 of the Federal FD&C Act codifies the 510(k) Third Party Review Program, which authorizes certain qualified third parties to conduct the initial review of premarket notification submissions...
United States
23 Nov 2018
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
SUPPORT Act Expands Sunshine Act Disclosure Requirements, Covered Recipients
One of the provisions of this lengthy bipartisan package of bills includes an expansion of the disclosure requirements initially imposed by the Physician Payments Sunshine Act.
United States
26 Oct 2018
SUPPORT Act Expands Sunshine Act Disclosure Requirements
On October 24, 2018, President Donald Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), ..
United States
25 Oct 2018
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
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
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
FDA Releases Revised Draft Memorandum Of Understanding For Human Drug Compounding
The revised MOU allows for information gathering and analysis of specific situations.
United States
2 Oct 2018
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
United States
19 Jul 2017
FDA Issues Final Guidance On Quality Agreements In Arrangements For Contract Manufacturing Of Drugs
The U.S. Food and Drug Administration (FDA) has released a final guidance, entitled "Contract Manufacturing Arrangements for Drugs: Quality Agreements," . . .
United States
4 Jan 2017
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
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
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
FDA Implements Expedited Review Of ANDA Submissions For "Sole-Source" Drug Products
The FDA recently updated its MAPP 5240.3 on Prioritization of the Review of Original ANDAs, Amendments and Supplements to Revision 2, adding a new category of expedited review of abbreviated new drug application submissions for "sole-source" drug products.
United States
4 Apr 2016
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