Tag Archives: Drug Safety

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 request expressing concerns about the safety and quality of generic drugs produced by manufacturers outside the United States. The OIG report contains an analysis of FDA's inspections of generic drug manufacturers over the past several years, and provides several recommendations for the FDA going forward.… Continue Reading

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 available for patient use. The House Energy and Commerce Committee’s “21st Century Cures Act” discussion draft, released on January 27, 2015, is a wide-reaching bill … Continue Reading

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 for a Writ of Certiorari with the U.S. Supreme Court, asking for review of the Ninth Circuit's decision in PhRMA v. County of Alameda, in which the court ruled that Alameda County's Safe Drug Disposal Ordinance - requiring pharmaceutical manufacturers to establish or participate in a program for collecting unwanted prescription drugs from consumers - was constitutional.… Continue Reading

County Ordinances Place Responsibility for Collection of Unwanted Pharmaceuticals on Manufacturers

The Alameda County (CA) Safe Drug Disposal Ordinance (Alameda County Code Chapter 6.53, §§ 6.53.010-6.53.120) is one of several county-wide regulations across the United States to enforce the establishment of and/or participation in Product Stewardship Plans on the part of pharmaceutical manufacturers, with the ultimate goal of collecting unwanted drugs for purposes of disposal. The … Continue Reading

China Life Sciences and Health Industry Client Briefing – November 2012 (December 13, 2012)

This post was written by Jay J. Yan, Hugh T. Scogin, Jr., John J. Tan, Mao Rong, Katherine Yang, May Wong, Amy Yin and Gordon B. Schatz. Reed Smith’s China Life Sciences and Health Industry Client Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life … Continue Reading

Food and Drug Law Institute’s Upcoming US-China Food and Drug Law Conference in Beijing, China

The Food and Drug Law Institute (FDLI) has an interesting upcoming conference on June 13-14 in Beijing, China that will address current legal, regulatory and economic issues regarding food, cosmetics, dietary supplements, pharmaceuticals and medical devices in China and the United States. Speakers are top government officials and internationally renowned experts who will discuss the issues in both countries.… Continue Reading

Upcoming Hearing on Draft Dingell/Waxman Drug Safety Legislation

On September 30, the House Energy and Commerce Committee is holding a hearing on draft drug safety legislation (per http://energycommerce.house.gov/index.php?option=com_jcalpro&Itemid=54&extmode=view&extid=230&date=2010-09-30, witness list not yet available). The legislation, which was drafted by Reps. John Dingell, Henry Waxman, Frank Pallone, and Bart Stupak, requires parity between foreign and domestic drug facility inspections, increases the number of pre-approval drug inspections, prohibits the entry of drugs into the United States lacking documentation of safety, requires manufacturers to ensure the safety of their supply chain, and grants FDA authority to mandate recalls of unsafe drugs. For background information on the draft legislation (including the text), see http://energycommerce.house.gov/index.php?option=com_content&view=article&id=2123:waxman-dingell-pallone-a-stupak-open-discussion-on-potentially-historic-changes-in-drug-safety-laws&catid=122:media-advisories&Itemid=55&layout=default&date=2010-10-01.… Continue Reading

House Energy & Commerce Drug Safety Hearing Set for March 10

As reported by our sister site, Health Industry Washington Watch, on Wednesday the House Energy and Commerce Health Subcommittee will hold a hearing entitled, "Drug Safety: An Update from the FDA." At the hearing, the FDA will detail its current challenges and successes in the area of drug safety. Joshua M. Sharfstein, M.D., FDA Principal Deputy Commissioner, is slated to testify.… Continue Reading

Commentary: FDA’s New Good Reprint Practice Rule

Recent posts on www.lifescienceslegalupdate.com include: "Commentary: FDA's New Good Reprint Practice Rule". The Food and Drug Administration's new Good Reprint Practice ("GRP") Guidance went into effect January 2009. The GRP Guidance establishes criteria that FDA will now use to determine whether the distribution of medical or scientific reprints and reference texts about off-label uses of a drug or device would constitute impermissible promotional activity under the Food, Drug and Cosmetic Act. http://www.lifescienceslegalupdate.com/2009/01/articles/regulatory-developments/commentary-fdas-new-good-reprint-practice-rule/ ...and "Dept. of Bad Ideas: Criminalization of Product Liability" regarding the 2006 proposal by Senator Arlen Specter (R.-PA) to criminalize aspects of product liability law. http://www.lifescienceslegalupdate.com/2009/01/articles/product-liability/dept-of-bad-ideas-criminalization-of-product-liability/… Continue Reading

Good Reprint Practices

Recent posts on www.lifescienceslegalupdate.com include: - "Good Reprint Practices" - "Secure Supply Chain Pilot Program" - "Increasing Clinical Trial Enrollment; Comments Requested" - "Good Importer Practices Draft Guidance" - "Submission of Bioequivalence Data" - "Current Good Tissue Practice Draft Guidance" - "Standardized Numerical Identification for Prescription Drug Packages" - "Certifications of Clinical Trial Registry/Results Submissions; Final Guidance" - "Submission of Laboratory Packages by Accredited Laboratories"… Continue Reading

Secure Supply Chain Pilot Program

The FDA published a notice January 15, 2009 announcing the launch of a voluntary Secure Supply Chain pilot program to help promote the safety of imported drugs and active pharmaceutical ingredients (APIs). According to the FDA, the program would enable the FDA to focus its resources on imported drugs that fall outside the program and that … Continue Reading

Good Importer Practices Draft Guidance

On January 13, 2009, the FDA announced on behalf of the Interagency Working Group on Import Safety the availability of draft guidance on “Good Importer Practices.”  The draft guidance document provides general recommendations to importers on possible practices and procedures they may follow to increase the likelihood the products they import (including drugs) comply with applicable … Continue Reading

Standardized Numerical Identification for Prescription Drug Packages

The FDA has released draft guidance on “Standards for Securing the Drug Supply Chain – Standardized Numerical Identification for Prescription Drug Packages,” which recommends standards industry should use for the identification of individual packages containing prescription drugs under the FDAAA. The standards are designed to facilitate adoption of a uniform electronic track and trace system for … Continue Reading

Submission of Laboratory Packages by Accredited Laboratories

On January 16, 2009, the FDA published a notice announcing “Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories,” which is intended to enhance the quality and reliability of test results submitted by importers to demonstrate that their products meet the FDA’s requirements. The guidance advises importers how to use accredited laboratories and … Continue Reading
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