The US Food and Drug Administration (FDA) was busy in 2023 with significant, and even bullish, developments occurring across several areas, from drug and biologic development and manufacturing to labeling, advertising, and...more
In a continuing effort to improve the quality system effectiveness of human drug manufacturing sites, FDA revised MAPP 5014.1, Understanding CDER’s Risk-Based Site Selection Model (Site Selection MAPP or the Policy)....more
While the US Court of Appeals for the Fifth Circuit has temporarily stayed the Texas district court’s ruling invalidating the US Food and Drug Administration’s (FDA’s) approval of mifepristone, the decision will still...more
On October 17, 2022, the US Food and Drug Administration (FDA) implemented revisions to two of its compliance policy guides (CPGs). CPGs are intended to advise FDA staff as to the agency's strategy when assessing and...more
The US Senate voted on February 15 to confirm Dr. Robert M. Califf as the next commissioner of the US Food and Drug Administration (FDA), a position that has been filled since April 2021 by acting commissioner Dr. Janet...more
The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that specifies the procedures and principles...more
A bipartisan group of lawmakers in the US House of Representatives’ Judiciary Antitrust Subcommittee recently voted three bills out of committee that target the pharmaceutical industry practices of so-called “reverse...more
8/16/2021
/ AMG Capital Management LLC v FTC ,
Antitrust Violations ,
Biosimilars ,
Competition ,
Exclusive Licenses ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
FTC Act ,
Generic Drugs ,
Hatch-Waxman ,
Manufacturers ,
Noerr-Pennington Doctrine ,
Pharmaceutical Industry ,
Reverse Payment Settlement Agreements
January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on...more
As the United States races to deliver safe and effective coronavirus (COVID-19) vaccines under the Biden administration, employers, healthcare providers, and many others are assessing what it means for their industries and...more
2/1/2021
/ Americans with Disabilities Act (ADA) ,
Civil Rights Act ,
Coronavirus/COVID-19 ,
Employer Liability Issues ,
Employment Policies ,
Equal Employment Opportunity Commission (EEOC) ,
Infectious Diseases ,
Life Sciences ,
Pharmaceutical Industry ,
Public Health ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Reasonable Accommodation ,
Title VII ,
Vaccinations ,
Wage and Hour ,
Workplace Safety
Under President Joe Biden, pharmaceutical regulation may see increased FDA guidance, new strategies to speed up innovation and regulatory review, and a renewed focus on diseases with unmet needs, among other expectations....more
1/27/2021
/ Biden Administration ,
Critical Infrastructure Sectors ,
Enforcement Actions ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Healthcare Reform ,
Innovation ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Reform ,
Supply Chain
The coronavirus (COVID-19) pandemic continues to impact the biopharmaceutical industry. In a recent guidance, Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency (the...more
Welcome to the August 2020 issue of our Life Sciences International Review. This issue covers new developments within Asia, Europe, and the United States in intellectual property, regulatory, pricing, and international trade,...more
8/24/2020
/ Asia ,
Coronavirus/COVID-19 ,
Digital Health ,
EU ,
Food and Drug Administration (FDA) ,
Force Majeure Clause ,
Foreign Direct Investment ,
Fraud ,
Life Sciences ,
Medical Devices ,
Over The Counter Drugs (OTC) ,
Patent Terms ,
Pharmaceutical Industry ,
Prescription Drugs
As the coronavirus (COVID-19) pandemic resurges, PREP Act liability immunity continues to be critical for manufacturers and users of COVID-19 medical products. ...more
The US Food and Drug Administration (FDA) announced on July 10 that it will resume domestic inspections of regulated facilities and activities using a new risk assessment rating system....more
From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more
7/1/2020
/ Biologics ,
Biosimilars ,
CGMP ,
Clinical Trials ,
Coronavirus/COVID-19 ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Requirements ,
Research and Development
In light of the coronavirus (COVID-19) outbreak, the US Food and Drug Administration (FDA) recently issued a guidance on adverse event (AE) report for drugs, biologics, medical devices, dietary supplements, and other products...more
The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9...more
4/5/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Drug Distribution ,
Federal Loans ,
Financial Stimulus ,
Food Manufacturers ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Distribution ,
Pharmaceutical Industry ,
Prescription Drugs ,
Relief Measures ,
Small Business ,
Suppliers
In light of the hand sanitizer shortage during the coronavirus (COVID-19) emergency, many companies have been trying to find alternative sources of product, especially employers in healthcare and essential service sectors...more
With the increasing numbers of coronavirus (COVID-19) cases and the declaration of a global pandemic by the World Health Organization, the pharmaceutical and biotech industries are assessing how this situation may impact...more
As the coronavirus (COVID-19) pandemic continues to grow, the US Food and Drug Administration (FDA) on March 18 issued a guidance document titled FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19...more
The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had...more
3/16/2020
/ Biotechnology ,
Center for Drug Evaluation and Research (CDER) ,
China ,
Clinical Trials ,
Contingency Plans ,
Coronavirus/COVID-19 ,
Crisis Management ,
Food and Drug Administration (FDA) ,
Imports ,
Infectious Diseases ,
Life Sciences ,
Pharmaceutical Distribution ,
Pharmaceutical Industry ,
Public Health ,
Supply Chain
EU – REGULATORY -
Brexit, Notified Bodies, and Medical Devices -
The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more
8/20/2019
/ Anti-Kickback Statute ,
Asia ,
China ,
Competition ,
Data Privacy ,
Drug Pricing ,
EU ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
UK Brexit
As precision medicine gains momentum and in vitro diagnostics (IVDs) become increasingly used in clinical trials, pharma and biotech companies will need to develop expertise in evaluating IVD risk and, if working with IVD...more
The 21st Century Cures Act contains significant new mandates for both the FDA and NIH that affect the pharmaceutical and biotechnology industries and are intended to advance drug research, discovery, approval, and promotion...more
The draft guidance provides insight into FDA’s expectations regarding data controls and compliance for pharmaceutical companies.
In recent years, issues involving the integrity of and controls around manufacturing data...more