Searching Content indexed under Life Sciences, Biotechnology & Nanotechnology 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FDA Releases Draft Guidance on Voluntary Recalls
The Food and Drug Administration (FDA) recently released a draft guidance on voluntary recalls.
United States
30 May 2019
DOJ Implements Granston Memo: Motions To Dismiss Filed In 11 False Claims Act Cases
In early 2018, the U.S. Department of Justice announced a new policy encouraging prosecutors handling False Claims Act (FCA) cases to seek dismissal of qui tam complaints that threaten the government's interests.
United States
9 Jan 2019
FDA Announces New UDI Compliance Deadlines Via Another Guidance Document
On September 24, 2013, the Food and Drug Administration (FDA) issued a "final" rule regarding the Unique Device Identification System to adequately identify devices through distribution and use
United States
4 Jan 2019
New FDA Draft Guidance On Uncertainty Considerations In Benefit-Risk Determinations For Medical Device Premarket Approvals
FDA provides authorization for marketing a device when its benefits outweigh its risks.
United States
30 Nov 2018
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
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 Issues Final Hatch-Waxman Regulations
The FDA issued a Final Rule to implement provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, entitled "Abbreviated New Drug Applications and 505(b)(2) Applications."
United States
13 Oct 2016
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 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
Compounding Pharmacy Co-Owner Pleads Guilty To Misdemeanor Criminal Violations Of The Food, Drug, And Cosmetic Act
The U.S. Food and Drug Administration, acting through the U.S. Department of Justice appears to have relied on the Park Doctrine to hold a corporate officer of a compounding pharmacy criminally responsible for the pharmacy's violations of the Federal Food, Drug, and Cosmetic Act (FDCA).
United States
22 Dec 2014
FDA Policy Aims To Smooth Generic Access To Samples Of Branded Drugs Subject To REMS Use Restrictions
The Food and Drug Administration (FDA) has attempted to remove, at least in part, a legal hurdle that had created challenges for generic drug companies.
United States
17 Dec 2014
FDA Report On Standardizing And Evaluating Risk Evaluation And Mitigation Strategies (REMS)
The U.S. Food and Drug Administration recently published a report titled "Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)".
United States
2 Dec 2014
FDA Publishes Second Draft Guidance For Further Clarification Of Drug Supply Chain Security Act
Earlier this year, the U.S. Food and Drug Administration requested information and commentary for the implementation of the Drug Supply Chain Security Act.
United States
18 Nov 2014
FDA's Final Guidance On Determination Of Five-Year NCE Exclusivity For Certain Fixed-Combination Drug Products Under Federal FDCA
The U.S. Food and Drug Administration recently published its final Guidance for Industry detailing circumstances under which a fixed-combination drug product may be entitled to five-year new chemical entity exclusivity.
United States
11 Nov 2014
FDA Issues Draft Guidances For Prior Approval Supplements And Amendments / Easily Correctable Deficiencies Under GDUFA
The Generic Drug User Fee Amendments of 2012 were signed into law "to speed access to safe and effective generic drugs to the public and reduce costs to industry."
United States
5 Aug 2014
FDA Issues Draft Guidance For Identification And Notification Of Suspect Products
The Drug Supply Chain Security Act was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs..."
United States
25 Jun 2014
FDA Releases Guidance For Industry On ANDAs: Stability Testing Of Drug Substances And Products, Questions And Answers
The FDA published a new Guidance for Industry, which provides answers to questions from public comments received on the draft Guidance for Industry on ANDAs.
United States
23 Jun 2014
Chapter 8: Krelec et al. v. Mutual Pharmaceuticals Co., Inc.
Attorneys Frederick R. Ball and Carolyn A. Alenci authored Chapter 8 in the FDLI publication Top 20 Food and Drug Cases, 2013 & Cases to Watch 2014.
United States
1 May 2014
FDA Issues Guidance On Dietary Supplement cGMP Regulations
In its recent guidance on the Dietary Supplement Current Good Manufacturing Practice Rule ("the DS cGMP"), the U.S. Food and Drug Administration (FDA) has provided a detailed road map of the requirements set forth in the regulations at 21 C.F.R. § 111.
United States
11 Feb 2011
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