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- Feed Preview | Life Sciences Legal Update
House Easily Passes 21st Century Cures Legislation, Includes Significant FDA Reforms
On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and im...
Alameda Drug Disposal Ordinance: Supreme Court Denies Petition for Writ
The United States Supreme Court has declined to hear a challenge to the Alameda County Drug Disposal Ordinance (“Ordinance”) brought by three pharmaceutical trade organizations. The Court...
Proposed 21st Century Cures Act Addresses Off-Label Promotion Issues for Drugs and Devices
Over on the Health Industry Washington Watch blog, Reed Smith attorneys Katie Pawlitz and Jeremy Alexander highlight the proposed changes to the Sunshine Act contained within H.R. 6, the “21st ...
OIG Report: FDA Has Made Progress on Oversight/Inspections of Manufacturers of Generic Drugs
On May 5, the Office of Inspector General (OIG) issued a report entitled "FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs" in response to a Congressional requ...
Bipartisan Energy & Commerce Committee Leaders Release Updated 21st Century Cures Draft
The bipartisan leadership of the House Energy and Commerce Committee has released their 2015 version of the 21st Century Cures Act, which is intended to bolster medical discovery, treatment devel...
The SEC and the Pharmaceutical Industry – Recent Commenta...ector Identifies Areas of SEC Focus Applicable to the Industry
Andrew Ceresney, enforcement director of the U.S. Securities and Exchange Commission (SEC), recently gave a presentation at CBI's Annual Pharmaceutical Compliance Congress in which he highlighted...
FDA Draft Guidance Addresses Electronic Informed Consent in Clinical Investigations
FDA has issued a draft guidance providing recommendations for clinical investigators, sponsors and institutional review boards on the use of electronic informed consent for FDA-regulated clinical...
Recent Regulatory Actions on Advertisement Disclosures
An article in Compliance Week discusses recent actions by the Federal Trade Commission (FTC) and Food and Drug Administration concerning advertisement disclosures. The FTC launched Operation Full...
U.S. Congressional Committees Address Drug And Device Approval
As mentioned on our Health Industry Washington Watch blog, committees in both the House of Representatives and Senate last week addressed the speed at which medical innovations are approved and a...
Drug Disposal Ordinance: Supreme Court Writ Filed
The Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), and the Generic Pharmaceutical Association (GPhA) have jointly filed a Petition fo...