Peter Reichertz

Peter Reichertz

Sheppard Mullin Richter & Hampton LLP

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New FDA Draft Guidance on REMS and Bioequivalence Studies: Does New Procedure Secure ANDA Applicants The Right to Obtain Samples?

Applicants seeking approval of Abbreviated New Drug Applications (ANDAs) in most cases must perform bioequivalence studies comparing their proposed generic product to the innovator drug listed in the Orange Book, called the...more

1/6/2015 - ANDA FDA Generic Drugs New Guidance Pharmaceutical Manufacturers Pharmaceutical Patents Prescription Drugs

Sandoz and Celltrion Decline the Invitation to Dance: Biosimilars Challenge the Applicability of the BPCIA’s Exchange Provisions...

In our blog post of November 18, 2013 (“No Avoiding BPCIA For Biosimilars: No Patent Declaratory Judgment Before Biosimilars Application is Filed”), we discussed the decision of the U.S. District Court for the Northern...more

11/13/2014 - Amgen Biosimilars BPCIA Declaratory Judgments FDA Patent Infringement Patent Litigation Patents Popular Public Health Service Act Sandoz

A Short-Lived Victory for Generic Manufacturers? – Part 2

In our prior blog post of the same title on July 5, 2013, we predicted that the protection from product liability/failure to warn litigation for generic manufacturers as a result of the Supreme Court decision in Mutual...more

1/2/2014 - ANDA Drug Manufacturers FDA Generic Drugs Pharmaceutical

No Avoiding BPCIA For Biosimilars: No Patent Declaratory Judgment Action Before Biosimilars Application Is Filed

The United States District Court for the Northern District of California ruled November 12, 2013, that a party seeking to obtain approval of a biosimilar could not avoid the process set forth in the Biologics Price...more

11/20/2013 - Amgen Biosimilars BPCIA FDA Patents Pharmaceutical Prescription Drugs Sandoz

A Short-Lived Victory for Generic Drug Manufacturers?

On June 24, 2012, the U.S. Supreme Court handed down its decision in Mutual Pharmaceutical Co. Inc. v. Bartlett, 570 U.S. ____ (2013), finding that design-defect claims against generic drug companies are pre-empted where...more

7/8/2013 - Design Defects Drug Manufacturers FDA FDCA Generic Drugs Labeling Mutual Pharmaceuticals v Bartlett PLIVA v Mensing Preemption Prescription Drugs SCOTUS

FDA Issues Two Proposed Rules That Will Significantly Change Regulatory Requirements For Food Safety

The FDA Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011, proposes the most sweeping reform of U.S. food safety laws in more than 70 years. As part of the changes...more

2/5/2013 - FDA Food Manufacturers Food Safety FSMA Safety Precautions

FDA Issues Final Guidance on Filing PMAs and 510(k)s

On December 31, 2012, the U.S. Food and Drug Administration (FDA) issued two new guidance documents on the minimum threshold of acceptability for medical device premarket submissions, which are titled “Refuse to Accept Policy...more

1/5/2013 - FDA Medical Devices Premarket Approval Applications

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