Lexology (registration)

Lexology (registration)
Share

Lexology (registration)

 •  November 19

On November 16, 2017, the Food and Drug Administration (“FDA” or the “Agency”) will hold a public hearing on a proposed approach for sponsors seeking to market devices referencing drugs (“DRDs”) when the drug sponsor does not wish to collaborate with the sponsor of the device. FDA will accept comments to the docket until January 15, 2018. As...

Lexology (registration)

 •  November 14

On November 9, 2017, the Federal Circuit confirmed that the overall content of a generic drug manufacturer’s labeling, as well as real-world evidence of physician practices, inform the induced infringement analysis in Hatch-Waxman cases. Sanofi v. Watson Labs. Inc., No. 2016-2722 (Fed. Cir. Nov. 9, 2017). Specifically, Chief Judge Prost and Circuit...

Lexology (registration)

 •  October 23

Agnès Saint-Raymond, MD, Head of International Affairs at the European Medicines Agency (“EMA”), recently urged pharmaceutical companies to be “proactive” in preparing for Brexit, as there is still uncertainty around a potential Brexit transition period. Speaking at the Drug Information Association (DIA) forum for EU QPPVs that took place on 4 and...

Lexology (registration)

 •  October 21

After receiving comments on the draft of the Decision of the State Administration of Food and Drug Administration on Adjusting the Relevant Issues Concerning the Registration and Administration of Imported Drugs (the “Decision”) in March 2017, the China Food and Drug Administration (“CFDA”) published the finalised version of the Decision on 10...

Lexology (registration)

 •  October 19

Earlier this month, California passed two bills with significant implications for pharmaceutical manufacturers: one imposing prescription drug price transparency requirements, and another that prohibits certain types of co-pay coupons and other prescription drug discounting programs that lower patient cost-sharing amounts for prescription drugs....

Lexology (registration)

 •  October 16

In August 2016, the Food and Drug Administration issued a final rule to update and clarify the agency’s drug registration and listing regulations. The rule made some fairly substantial changes even though the rule became effective last November, and drug companies may just now start to feel the impact of some of the rule’s requirements. Of...

On July 18, 2017, FDA held a public meeting to address efforts to ensure a balance between innovation in drug development and accelerating the access of the public to lower-cost alternatives to innovator drug therapies is maintained under the Drug Price Competition and Patent Term Restoration Act (known as the Hatch-Waxman Amendments). Through the...

Clinical trials lawyer Gene Matthews has welcomed a push from the Federal Drug Agency (FDA) to promote safety and quality in clinical trials that are carried out in India. The blog describes the programme of engagement that the FDA is carrying out to promote the safety and efficacy of imported drugs. The programme includes inspections, targeted...

On May 5, 2017, the U.S. Court of Appeals for the Federal Circuit issued a non-precedential opinion reversing a decision of noninfringement under 35 U.S.C. § 271(e) by the U.S. District Court for the Southern District of New York. See Braintree Labs, Inc. v. Breckenridge Pharm., Inc., No. 2016-1731 (Fed. Cir. May 5, 2017) (“Braintree Opinion”)....

Lexology (registration)

 •  April 13

Last Wednesday, April 5, the Senate Committee on Health, Education, Labor, & Pensions held a hearing on the nomination of Scott Gottlieb, MD, as Commissioner of the Food and Drug Administration. As part of the hearing, Gottlieb was questioned on an array of topics from his prior service at FDA to his alleged financial interests in pharmaceutical...